Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Arthrosurface with 26 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated Jun 24, 2021: OVOMotion Reverse Shoulder Arthroplasty System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 24, 2021 | OVOMotion Reverse Shoulder Arthroplasty SystemK203375 · PHX | 510(k) clearances |
| Oct 15, 2020 | Arthrosurface WristMotion Total Wrist Arthroplasty SystemK200718 · JWJ | 510(k) clearances |
| Aug 14, 2019 | BOSS Toe Fixation SystemK190261 · KWD | 510(k) clearances |
| Jun 14, 2018 | Patello-Femoral Wave (Kahuna) Arthroplasty SystemK181280 · KRR | 510(k) clearances |
| Apr 18, 2018 | OVOMotion Shoulder Arthroplasty SystemK173964 · HSD | 510(k) clearances |
| Dec 22, 2017 | Arthrosurface Bone ScrewsK172383 · HWC | 510(k) clearances |
| May 3, 2017 | KISSloc Suture SystemK170440 · HTN | 510(k) clearances |
| Mar 3, 2017 | ToeMATE® Hammertoe Correction SystemK170350 · HWC | 510(k) clearances |
| Nov 24, 2014 | Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured ArticulClass II · Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | Device recalls |
| Nov 24, 2014 | Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured ArticClass II · Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | Device recalls |
| Nov 24, 2014 | Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Class II · Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | Device recalls |
| Nov 24, 2014 | Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured ArticularClass II · Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | Device recalls |
| Nov 24, 2014 | Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured ArticulaClass II · Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | Device recalls |
| Jun 9, 2014 | Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in questClass II · An oversight in the implementation of the design change record resulted in outdated components being shipped to customer | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
