510(k) Report

FDA applicant

Howmedica Corp.

Rutherford, NJ412 decisions1971–199949 recalls

FDA records 412 decisions for Howmedica Corp. (Rutherford, NJ) from 1971 to 1999: 409 510(k) clearances and 3 original PMA approvals. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and JDI (Prosthesis, Hip, Semi-Constrained…). Its devices cite 123 predicates, 78 of them its own earlier devices. 49 recalls are linked to its devices.

FDA’s records also spell it “Howmedica, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Howmedica Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Howmedica Corp. since 2007.

Recalls per year

13in 2023

2007: 112009: 12010: 32011: 12015: 22021: 12023: 13
2007high 13 (2023) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Howmedica Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Howmedica Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer47decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented43decisions
  • HRSPlate, Fixation, Bone27decisions
  • HSBRod, Fixation, Intramedullary And Accessories26decisions
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component22decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…19decisions

Also: LPH (18), JEC (13), HRY (12), HWC (12), EJS (10), EXB (9).

Whose devices does it build on?

Its devices cite 123 predicates; 78 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 346 times; 78 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K984251Xia Spine SystemHowmedica, Inc. · 199914cite it
  • K900926Trochanter Cable Grip System (Add'l Indications)Howmedica Corp. · 19909cite it
  • K961497Profyle Titanium Hand and Small Fragment SystemHowmedica, Inc. · 19969cite it
  • K974054Distal Centralizer, Exeter II Hip SystemHowmedica, Inc. · 19978cite it
  • K971755Hoffmann II Compact External Fixation SystemHowmedica Corp. · 19976cite it
  • K844068Trochanter Cable Grip SystemHowmedica Corp. · 19856cite it

What has FDA decided for it lately?

  • K984251Xia Spine SystemHowmedica, Inc. · 1999
  • K984202Howmedica Humeral Intercalary SystemHowmedica, Inc. · 1999
  • K984305Zeta Multizone Locking Nail SystemHowmedica, Inc. · 1999
  • K983885Burr Hole Covers, Craniomaxillofacial PlatesHowmedica, Inc. · 1999
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998
  • K980926Duration II Acetabular Components-Ethylene Oxide SterilizationHowmedica Corp. · 1998

All 376 as Howmedica Corp. →All 36 as Howmedica, Inc. →

What has been recalled?

49 recalls linked to its devices; the latest:

  • K940861LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number…Dec 1, 2023Class II
  • K936008PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031Dec 1, 2023Class II
  • K940861RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number…Dec 1, 2023Class II
  • K940861RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number…Dec 1, 2023Class II
  • K940861RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number…Dec 1, 2023Class II
  • K936008LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number…Dec 1, 2023Class II

Other applicant names beginning “Howmedica”

FDA records each applicant name separately; these may or may not be the same firm.

Howmedica Osteonics Corp. 303Howmedica Osteonics Corp., Dba Stryker Orthopaedics 34Howmedica Leibinger, Inc. 11Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics 11Howmedica, Pfizer Medical Technology Group 1Howmedica Osteonics Corp. Dba Stryker Orthopeadics 1