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510(k) K121315

STRYKER CMF MEDPOR CUSTOMIZED IMPLANT by Howmedica Osteonics Corp. — Product Code FWP

K121315 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "STRYKER CMF MEDPOR CUSTOMIZED IMPLANT". The FDA issued a decision of Substantially Equivalent on November 1, 2012. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2012
Date Received
May 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Howmedica Osteonics Corp.

  • K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (August 13, 2020)
  • K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Tri (May 13, 2020)
  • K130895 — REUNION RSA SHOULDER SYSTEM (December 27, 2013)
  • K123604 — ABG III MONOLITHIC HIP STEM (August 16, 2013)
  • K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CI (February 22, 2013)
  • K123166 — TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON A (February 14, 2013)
  • K122853 — NOVEL FIT AND FILL STEM (February 1, 2013)
  • K121308 — HIP SYSTEMS (July 30, 2012)
  • K120578 — ACCOLADE II HIP STEM (March 29, 2012)
  • K113409 — S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESS (February 15, 2012)

Other clearances for product code FWP

  • K254233 — MEDPOR Customized Implant Kit (March 12, 2026)
  • K232593 — FITme Customized Silicone Implant (November 22, 2023)
  • K200610 — Customized Contour Implant (December 23, 2020)
  • K191130 — Customized Contour Implant (August 23, 2019)
  • K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit (August 15, 2019)
  • K153508 — Stryker CMF MEDPOR Customized Implant (February 5, 2016)
  • K152463 — SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (January 20, 2016)
  • K143173 — Stryker CMF MEDPOR Customized Implant (March 23, 2015)
  • K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, S (July 10, 2014)
  • K091011 — PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) (April 22, 2009)

FDA data resources