Arthrosurface, Inc.
Arthrosurface, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2021, with 6 FDA device recalls on record.
Top product codes for Arthrosurface, Inc.
FDA recalls by Arthrosurface, Inc.
- Z-1114-2015 — Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
- Z-1112-2015 — Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
- Z-1113-2015 — Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
- Z-1111-2015 — Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
- Z-1110-2015 — Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
- Z-0475-2016 — Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Arthrosurface, Inc.
- K203375 — OVOMotion Reverse Shoulder Arthroplasty System
- K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System
- K190261 — BOSS Toe Fixation System
- K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System
- K173964 — OVOMotion Shoulder Arthroplasty System
- K172383 — Arthrosurface Bone Screws
- K170440 — KISSloc Suture System
- K170350 — ToeMATE® Hammertoe Correction System
- K162391 — AlignMATE Lapidus Arthrodesis System
- K161539 — Arthrosurface Bone Screws
- K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System
- K141920 — Wrist Hemiarthroplasty System
- K142942 — HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
- K133835 — ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
- K140617 — PINIT SMALL BONE FUSION SYSTEM
- K132496 — ARTHROSURFACE TOEMOTION
- K131377 — HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
- K130859 — HAMMERTOE CORRECTION SYSTEM
- K122334 — CHECKMATE SMALL BONE FUSION SYSTEM
- K113762 — CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
- K091196 — GRS GLENOID RESURFACING SYSTEM
- K071413 — HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM
- K063370 — CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
- K060127 — HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
- K050373 — UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
- K031859 — CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
Data sourced from openFDA. This site is unofficial and independent of the FDA.