Thursday, July 15, 2010


Today is the day fellow spineophiles! Oxford Performance Materials (OPM) is pleased to announce that a long-term implantable medical device manufactured with it OXPEKK-IG polymer has received clearance by the USFDA. The device is produced from OPM's radio opaque OXPEKK-IG. (Acronym Exhaustion) is produced by Kent Medical Devices a privately held Minnesota based company.

OPM has been in the commercial market in Europe, the Middle East and South America. Recently, the OXPEKK-IG polymer has received approval for the Korean market. So what is OXPEKK-IG? It is a high performance, ultra-pure thermoplastic with a modulus of elasticity similar to bone. Yes fellow spineophiles, it's PEKK not PEEK, a PolyEtherKetoneKetone (spell check worked this time), and is within the class of PAEK. So the bottom line is that this material has been used and implanted worldwide.

For those companies that may be interested in learning more about the biocompatibility of this material, data is available form OPM without any access fee. So in closing, we have a new player in the PEKK market and this material may be utilized for spinal cages (lookout Invibio), bone screws and k-wires, hip implant components, and knee replacement parts. So in closing, TSB has to ask our readers, are you down with OPP, or are you down with OXPEKK-IG?

Je voudrais un OXPEKK-IG pour mon cages!!!!!!!!!!!!!!


  1. Has it been cleared in a spine device? Or just long term implantable? Solvay have been cleared long term implantable for awhile. Has OPM satisfied the nuero-tox question @ CDRH?

  2. PEKK:
    Flexural yield strength = 138 MPa
    Compressive yield strength = 103 Mpa

    Flexural yield strength = 170 MPa
    Compressive yield strength = 118 Mpa

    Use a weaker material to save a few bucks? No thanks.

  3. @0942:
    Whose data sheet did THOSE figures leap from? Clearly you didn't do the homework...
    Those numbers are for one of several types of PEKK (unlike PEEK, there is more than one form of PEKK). The PEKK in current use around the world in implants, to include spine OUS, is more like:

    Flexural yield of 190 Mpa
    Compressive yield of 205 Mpa

    And "cheaper"? That hinges on the fees / royalties model more than anything else, eh?

  4. If there is, in fact, a 510(k) cleance using PEKK, then InVibio's world is about to be rocked.

    Couldn't happen to a more well deserving group of arrogant pricks.

  5. @ 7/15/10

    Whose data sheet did THOSE figures leap from?

    You can't call out someone else's lacking citation, and then spout your own data w/o citation.

    Jus' keeping it real over here.

  6. Why don't we go back to PEKEKK, like the first Brantigan cages? Oh yeah, and let's not forget to add the carbon fibers... Can anyone explain what the supposed advantage of this stuff it? Sounds like just another smooth plastic to me.

  7. @1109:

    *Whose data sheet did THOSE figures leap from?
    You can't call out someone else's lacking citation, and then spout your own data w/o citation.*

    A valid point.

    My numbers come from the data sheets the OXPEKK guys (OPM in CT, USA) publish. I am certain anyone that wants one could make contact through their website and check the figures (You have to ask for a medical data sheet, IIRC). I had expected that anyone actually interested would do so, if only to know the whole story (or as much as can be had) using info from independent sources. I think we all know, such can be tough to come by these days.

    Still - point taken - and I (we all?) await the source(s) of the other data...

  8. Congratulations Scott!

  9. Finally! Something to compete with Invibio's PEEK and the stranglehold it has had on the market for years. I just hope that all of these acronyms don't cause confusion amongst surgeons, and lead to a sense of distrust for implantable plastics in general.

    TSB, I'd like to hear what you think about the two "bone-adhesives" recently cleared by the FDA (OsteoCrete by Bone Solutions, Inc. and Kryptonite by Doctor's Research Group, Inc.). Do you think they have the potential to make a significant impact in the ortho and/or the orthospine markets? It seems like a pretty exciting concept...especially if they actually work as well as both companies claim.

  10. The PEKK Flexural yield strength of 138 MPa and Compressive yield strength of 103 Mpa come from the Matweb database for branched standard grade PEKK.

    If OxPEKK developed a higher performance formulation, then I stand corrected.

  11. @3:03PM
    Please note that PEKK is a copolymer - opposed to PEEK which is a monopolymer.
    Due to its copolymeric properties PEKK can be modified by changing the Terephthalic and Isophthalic acid ratio during the synthesis.
    OPM has currently a grade with amorphous behavior (OXPEKK-IG100) with a T/I ratio of 60/40 and a grade with a T/I ratio of 80/20 (OXPEKK-IG200 and OXPEKK-IG300) on the market.
    The OXPEKK-IG100 grade seems to be in the range of mechanical properties you cited.
    The OXPEKK-IG200 and OXPEKK-IG300 grade is most similar to the PEEK you all know, but with much better compressive strength and many other technical advantages over PEEK...

  12. MSM... You meant radiolucent in reference to this new PEKK material right? If so (assuming), then this could very well drive down the prices of spacers due to companies ability to discount further...

    Additionally, what are the thoughts on the carbon-fiber cages? DePuy seems to be doing OK while getting around Invibio's monopoly$ thoughts?

  13. I wouldn't say Depuy is thriving, been paying attention to the numbers?

  14. I think that the strength of OPM is in its Flexibility and ability to creat more and more application to the OXPEKK like films, bioflex fibers and more

  15. @July 15, 2010 6:10 PM, MSM meant radio-opaque PEKK material:
    However, radio-lucent PEKK is also available from the same source!

  16. @07/15/10 3:03:


    However, the *very next* line on the Matweb database search result for PEKK under the "branched grade" is the "linear grade", which carries the higher performance figures.

    A mistake, not a crime - most working in PEEK are conditioned to the annoying limitations of that resin system (including PEEK, PEK & PEKEKK) having only a single form, and would thus not have known to even look for another option.

    PEKK is pretty liberating, from what I hear from molders and other processors that have detoxed from the PEEK KoolAid. Well worth a closer look.

  17. At the end of the day its a good thing more PAEK's are being approved by the FDA. These approvals will allow for a more novel product developments and help lower costs associated with the current model.It will allow more individuals to start companies and compete rather than just the corporations. Eveyone should be in favor of more PAEK approvals.
    Its a wonder how a small company gets an FDA approval and the large corporations are still trying.

  18. @0922:

    Agreed - Competition is always a good thing - be it in spine or jet engines.

    Small companies actually DO blessed near all the innovating and barrier breaking these days. BellCore and PARC, both fabulous in their day, are shadows compared to former selves - likely due to fantastic overhead costs. SmallCo is low overhead and agile by necessity.

    Further - At the question I am forced to wonder: Are the BigCo's ~really~ trying?...

  19. The cage market is already impossibly crowded with small players driving prices into the basement. People may curse Invibio, but at least they kept out the bottom feeders who couldn't come up with a couple hundred grand for a license.

    Now that the barrier of entry is even lower, expect price erosion to accelerate. It won't be long before companies are fighting to practically give cages away.

  20. @1011:

    Detritus brings bottom feeders. In fact, there can be no bottom feeders without.

    If all you have is a brick with a hole in it, you have no competitive advantage. Lacking some material, process or design that is not readily reverse engineered AND provides unique benefit or utility, you have no (and should have no) real protection against competition.

    Those entrepreneurs on city streets hawking bags that ~look~ much like a Coach - but do not say Coach - are only responding to market forces. How different is the 'knockoff' from the 'real thing' - given that they are BOTH made in the same factories in China?

    Mutate or Die, say the biologists.
    They are right.

  21. "A turd by any other name... would still smell the same."

    Still ALL polymer based plastics.
    Nothing new here.

    Crapola that will drive pricing down as it is clearly a commodity made of the cheapest stuff on earth. Plastic.

    big flippin deal.

    I'm suprised the 'evil empire' didn't think of it first... they are the 'repackaging' smoke and mirrors geniuses of this industry.

    oh well... I mean, smell.

  22. CFRP: Carbon Fiber Reinforced POLYMER.
    ah, crap... nothing new their either... although modules of elasticity are closer with it... so, it's been out for years. Why all the talk about this new plastic that is 'softer'.

    Big flippin deal...

    CFRP has TONS more clinical data and evidence than this new plastic.

    I just don't get it.

    Go innovate something will ya?!!!

  23. Is modules of elasticty the most important piece of IB? If so, are there any papers out there that site better outcomes? CFRP???

    Seems like my docs are more about their biologics. I've been with several different companies and the only thing they are loyal to is BMP/Biologics.

  24. I agree the future is all about biologics. how many ways can you redesign a square.

  25. The folks at OPM have been thinking about this subject too. I hear they have introduced OSTEOFAB. This is a direct additive digital manufacturing process using a grade of PEKK with published 12,000 psi ultimate tensile strength, 2% elongation and 600,000 Tensile modulus. I guess now the only limit to design is imagination.

  26. OK - we can agree that we need something.

    Metal-heads bashing polymers and biologic-philes bashing everything are not offering anything useful. The brick-with-a-hole thing is self-explanatory.

    So... What?

    Isn't the availability of a second / third polyketone that creates competition not important?

    Isn't the expanded use of diagnostic imaging without the artifacts generated by metals enough of a benefit to warrant polymer use?

    What modulus values are we seeking? "More" than or "closer" to... What? Isn't Ti6/4 or CoCr already TOO stiff, creating shielding & remodeling? At least with a polymer / fiber system, we can MAKE the modulus what we want (not to be confused with the Stiffness of the part we may design using the material with a Modulus).

    "How many ways can you redesign a square?" Indeed - if one is stuck with swiss machining, not many. Injection molding ditto. A recent post mentioned the PEKK guys having direct digital manufacturing - now THAT is a way to manufacture UNIQUE geometries in relatively low volumes. Imagine - no tooling costs for molding. No costly prototype machining (should be same price as production or near to it - there must be a setup fee, I suppose) - read this as cheap design iteration - make 20 each of 20 iterations with only one setup.

    Glorious, liberating, and, as yet unseen.

    New enough for you?

  27. Anyone seen Amedica Spine's new silicon nitrate implants? Thoughts?

  28. coligne has 510 (k)'s on lumbar plates and cages made of Long fiber carbon PEKEKK -- they can control the orientation of the fiber -- better cellular adhesion and control of strength and modulus -- this is why carbon composites are better than pure polymers.

  29. Is Coligne actually making such cages? Last I heard, the PEKEKK they used went out of production ages ago. Was there ever any clinical feedback 'from the wild'?...