510(k) Report

FDA applicant

Kinetikos Medical, Inc.

San Diego, CA19 decisions1994–20063 recalls

FDA records 19 decisions for Kinetikos Medical, Inc. (San Diego, CA) from 1994 to 2006: 19 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal…). Its devices cite 30 predicates, 6 of them its own earlier devices. 3 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 Kinetikos Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kinetikos Medical, Inc. since 2007.

Recalls per year

3in 2019

2019: 3
2007high 3 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • HWCScrew, Fixation, Bone7decisions
  • JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained3decisions
  • HRSPlate, Fixation, Bone3decisions
  • LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained1decision
  • HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1decision
  • HXBProbe1decision

Also: KWD (1), KWI (1), JDK (1).

Whose devices does it build on?

Its devices cite 30 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 50 times; 6 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.

  • K960692Subtalar Mba SystemKinetikos Medical, Inc. · 19969cite it
  • K991873Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 19997cite it
  • K023770K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)Kinetikos Medical, Inc. · 20027cite it
  • K961051Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 19963cite it
  • K024233Kompressor Screw SystemKinetikos Medical, Inc. · 20033cite it
  • K020554Modification to Universal Total Wrist SystemKinetikos Medical, Inc. · 20023cite it

What has FDA decided for it lately?

  • K061749Eclipse Total Ankle ImplantKinetikos Medical, Inc. · 2006
  • K061465Kmi Cement Restrictor ImplantKinetikos Medical, Inc. · 2006
  • K051611Mbaresorb ImplantKinetikos Medical, Inc. · 20053 recalls
  • K041461Kmi Distal Volar Radius Plate SystemKinetikos Medical, Inc. · 2004
  • K032806Katalyst Radial Head ImplantKinetikos Medical, Inc. · 2004
  • K040356Kompressor Screw SystemKinetikos Medical, Inc. · 2004
  • K024233Kompressor Screw SystemKinetikos Medical, Inc. · 2003
  • K030037Universal Total Wrist SystemKinetikos Medical, Inc. · 2003

All 19 as Kinetikos Medical, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K051611Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product…Mar 1, 2019Class II
  • K051611Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product…Mar 1, 2019Class II
  • K051611Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product…Mar 1, 2019Class II