CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM— 510(k) K023096

Name: FDA 510(k) clearance K023096
Creator: U.S. Food and Drug Administration
Published: 2003-04-10

Substantially Equivalent

Std Mfg., Inc.

FDA 510(k) clearance K023096 for CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM, Substantially Equivalent on 2003-04-10. Applicant: Std Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Std Mfg., Inc.
Product code: Code HSD
Device class: Class 2
Regulation: 21 CFR 888.3690
Advisory panel: Orthopedic
Date received: 2002-09-18
Decision date: 2003-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSD

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K233260 — Univers Revers CA Head and Adapter2024-02-12
K221232 — Univers Revers Humeral Cup Implant2022-05-19
K191433 — AGILON® XO Shoulder Replacement System2020-11-12
K193122 — Biocore9 Humeral Resurfacing System2020-05-15
K173964 — OVOMotion Shoulder Arthroplasty System2018-04-18

More clearances from Std Mfg., Inc.

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K021549 — CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM2002-08-01
K012362 — MODIFICATION TO VASCULAR CLOSURE DEVICE2001-08-23
K003169 — VASCULAR CLOSURE DEVICE2000-12-08
K000608 — SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM2000-03-07
K930427 — STD IRRIGATION PUMP1993-06-01

Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K023096

K-number listed on FDA's recall record

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.Class II·Terminated·Arthrosurface, Inc.·20141124
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.Class II·Terminated·Arthrosurface, Inc.·20141124
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.Class II·Terminated·Arthrosurface, Inc.·20141124
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.Class II·Terminated·Arthrosurface, Inc.·20141124
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.Class II·Terminated·Arthrosurface, Inc.·20141124

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023096.

Data sourced from openFDA. This site is unofficial and independent of the FDA.