FDA applicant

Arthrosurface, Inc.

Franklin, MA26 decisions2004–20214 recalls

FDA records 26 decisions for Arthrosurface, Inc. (Franklin, MA) from 2004 to 2021: 26 510(k) clearances. Most are in product codes KWD (Prosthesis, Toe, Hemi-, Phalangeal) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 107 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 66 predicates, 18 of them its own earlier devices. 4 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 Arthrosurface, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007high 5 (2014) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2022

2007high 3 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Arthrosurface, 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?

KWDProsthesis, Toe, Hemi-, Phalangeal5decisions
HWCScrew, Fixation, Bone4decisions
HRSPlate, Fixation, Bone4decisions
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer3decisions
HTNWasher, Bolt Nut2decisions
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2decisions

Also: KWN (1), PHX (1), HSX (1), KWS (1), JWJ (1), LZJ (1).

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 107 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 127 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 66 predicates; 18 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 41 times; 18 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.

K031859Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 20049cite it
K130859Hammertoe Correction SystemArthrosurface, Inc. · 20134cite it
K060127Hemicap Patello-Femoral Resurfacing ProsthesisArthrosurface, Inc. · 20064cite it
K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc. · 20093cite it
K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 20133cite it
K071413Hemicap Patello-Femoral Resurfacing SystemArthrosurface, Inc. · 20072cite it

What has FDA decided for it lately?

K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc. · 2021
K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020
K190261BOSS Toe Fixation SystemArthrosurface, Inc. · 2019
K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. · 20183 recalls
K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018
K172383Arthrosurface Bone ScrewsArthrosurface, Inc. · 2017
K170440KISSloc Suture SystemArthrosurface, Inc. · 2017
K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc. · 2017

All 26 as Arthrosurface, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

K181280MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008Dec 22, 2022Class II
K181280MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008Dec 22, 2022Class II
K181280MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013Dec 22, 2022Class II
K132496Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange…Jun 9, 2014Class II