510(k) Report

FDA applicant

Biopro, Inc.

Port Huron, MI41 decisions1987–201733 recalls

FDA records 41 decisions for Biopro, Inc. (Port Huron, MI) from 1987 to 2017: 41 510(k) clearances. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and HWC (Screw, Fixation, Bone). Its devices cite 48 predicates, 3 of them its own earlier devices. 33 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 Biopro, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2007: 12008: 22009: 22010: 22012: 12013: 22017: 2
2007high 2 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

5in 2025

2011: 22019: 162022: 102025: 5
2007high 16 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Biopro, Inc.’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?

  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented7decisions
  • HWCScrew, Fixation, Bone3decisions
  • KWDProsthesis, Toe, Hemi-, Phalangeal3decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…3decisions
  • HRSPlate, Fixation, Bone3decisions
  • JDRStaple, Fixation, Bone2decisions

Also: KXA (2), HSB (2), KYI (2), KWY (2), JWH (2), KWL (2).

Whose devices does it build on?

Its devices cite 48 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 51 times; 3 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.

  • K041595Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870Biopro, Inc. · 20047cite it
  • K904448Townley Total Knee (TTK)Biopro, Inc. · 19916cite it
  • K911378Townley Great Toe JointBiopro, Inc. · 19915cite it
  • K081149Biopro GO-EZ ScrewBiopro, Inc. · 20085cite it
  • K061798Biopro Memory StapleBiopro, Inc. · 20064cite it
  • K082705Biopro Bipolar Head, Models 18130-18152Biopro, Inc. · 20084cite it

What has FDA decided for it lately?

  • K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc. · 2017
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017
  • K132510Biopro - Infinity Plate Anchor SystemBiopro, Inc. · 2013
  • K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013
  • K121973Biopro Hemi-Edge Toe SystemBiopro, Inc. · 2012
  • K100761Biopro Polar HeadBiopro, Inc. · 20101 recall
  • K101030Modification to HBS Headless Bone ScrewBiopro, Inc. · 20102 recalls
  • K090208Biopro Femoral HeadsBiopro, Inc. · 20093 recalls

All 41 as Biopro, Inc. →

What has been recalled?

33 recalls linked to its devices; the latest:

  • K872856BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD…Sep 9, 2025Class II
  • K090208BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part…Sep 9, 2025Class II
  • K895886BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38…Sep 9, 2025Class II
  • K100761BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD…Sep 9, 2025Class II
  • K912641BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL…Sep 9, 2025Class II
  • K041595Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035Feb 1, 2022Class II

Other applicant names beginning “Biopro”

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

Biopro (M) Sdn Bhd 5