APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)— 510(k) K954800

Clearance details

Applicant

Intermedics Orthopedics

Product code

Code MEH

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

1995-09-27

Decision date

1996-04-25

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Austin, TX, US

• K261576 — Icona Hip Stem2026-08-10
• K250375 — Allure Hip Stem and Intramedullary Plugs2025-11-05
• K251166 — Mfinity Femoral System2025-06-13
• K251052 — Trivicta® Hip Stem2025-05-22
• K242315 — Resolve Modular Revision Hip Stem2025-05-01

• K970300 — NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI1997-07-03
• K970498 — NATURAL-KNEE II REVISION FEMORAL SPACER LUGS1997-04-30
• K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM1997-04-08
• K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS1997-02-27
• K964357 — NATURAL-HIP SYSTEM COCR STEM1997-01-27

Injury

2,021

Total

2,021

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 →

• Z-1135-2105 — CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint diseaseClass II·Terminated·Zimmer Gmbh·20141217

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954800.