510(k) Report

FDA applicant

Stryker Orthopaedics

Mahwah, NJ24 decisions2004–202142 recalls

FDA records 24 decisions for Stryker Orthopaedics (Mahwah, NJ) from 2004 to 2021: 24 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and MBH (Prosthesis, Knee, Patello/Femorotibial…). Since 2016 its 510(k)s took a median of 82 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 160 predicates, 19 of them its own earlier devices. 42 recalls are linked to its devices.

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 Stryker Orthopaedics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 42008: 12013: 12014: 22015: 32016: 12017: 12018: 22019: 12021: 1
2007high 4 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

3in 2024

2007: 12008: 22013: 12015: 22016: 32017: 22018: 22019: 42020: 162021: 52023: 12024: 3
2007high 16 (2020) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Stryker Orthopaedics’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?

  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented6decisions
  • MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated…5decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…4decisions
  • MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium…2decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2decisions
  • HRSPlate, Fixation, Bone1decision

Also: JDG (1), LOD (1), HSD (1), JDI (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 82 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 104 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 160 predicates; 19 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 82 times; 19 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.

  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 201714cite it
  • K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 201413cite it
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 20168cite it
  • K053514Triathlon Total Knee SystemStryker Orthopaedics · 20067cite it
  • K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 20137cite it
  • K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 20156cite it

What has FDA decided for it lately?

  • K211703Insignia Hip StemStryker Orthopaedics · 2021
  • K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 20182 recalls
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 20183 recalls
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 20171 recall
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 20161 recall
  • K151264Restoration Anatomic ShellStryker Orthopaedics · 201517 recalls
  • K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct…Stryker Orthopaedics · 20152 recalls

All 24 as Stryker Orthopaedics →

What has been recalled?

42 recalls linked to its devices; the latest:

  • K141056Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device…Sep 4, 2024Class II
  • K173849X3 Triathlon CS Insert NO 3 10 MMFeb 6, 2024Class II
  • K173849X3 Triathlon CS Insert NO 6 10 MMFeb 6, 2024Class II
  • K173849TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog…Apr 13, 2023Class II
  • K17349928MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028Oct 15, 2021Class II
  • K17349928MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122Oct 15, 2021Class II

Other applicant names beginning “Stryker”

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

Stryker Corp. 354Stryker Endoscopy 103Stryker Instruments 77Stryker Spine 76Stryker Leibinger GmbH & Co KG 36Stryker Neurovascular 36Stryker Sustainability Solutions 34Stryker Trauma AG 32Stryker Medical 14Stryker Instruments, Instruments Div. 6Stryker Corporate 6Stryker Corporation (Tornier, Inc.) 5