PROFEMUR HIP SYSTEM MODULAR NECKS— 510(k) K091423

Clearance details

Applicant

Wrightmedicaltechnologyinc

Product code

Code KWA

Device class

Class 3

Regulation

21 CFR 888.3330

Advisory panel

Orthopedic

Date received

2009-05-13

Decision date

2009-08-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Arlington, TN, US

• K122778 — PROFEMUR Z REVISION HIP STEM2012-10-11
• K121544 — DYNASTY BIOFOAM SHELL2012-07-30
• K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS2012-05-18
• K113322 — CONSERVE THIN SHELL2012-02-03
• K112080 — PRESERVE HIP STEM2011-12-28

• K222835 — Prophecy Preoperative Navigation Alignment System2023-01-27
• K213342 — PRO-DENSE LoVisc Bone Graft Substitute2022-01-05
• K212996 — Sterile PHALINX Hammertoe System2021-11-16
• K202815 — PROPHECY Preoperative Navigation Alignment System2021-03-10
• K201259 — ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System2021-01-08

Death

38

Injury

10,439

Malfunction

1,862

Total

12,339

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-2948-2020 — PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME PHAC1222 PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME PHAC1224 PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME PHAC1232 PROFEMUR NECK A/R 8DG SHORT COBALT CHROME PHAC1234 PROFEMUR NECK A/R 8DG LONG COBALT CHROME PHAC1242 PROFEMUR NECK A/R 15DG SHORT COBALT CHROME PHAC1244 PROFEMUR NECK A/R 15DG LONG COBALT CHROME PHAC1252 PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME PHA01202 PROFEMUR NECK NEUTRALSHORT SHORT PHA01204 PROFEMUR NECK NEUTRAL LONG PHA01206 PROFEMUR NECK NEUTRAL X LONG PHA01212 PROFEMUR NECK A/R VAR/VAL 2 SHORT PHA01214 PROFEMUR NECK A/R VAR/VAL 2 LONG PHA01222 PROFEMUR NECK A/R VAR/VAL 1 SHORT PHA01224 PROFEMUR NECK A/R VAR/VAL 1 LONG PHA01232 PROFEMUR NECK 8DG A/R SHORT PHA01234 PROFEMUR NECK 8DG A/R LONG PHA01236 PROFEMUR NECK 8DG A/R X LONG PHA01242 PROFEMUR NECK 15DG A/R SHORT PHA01244 PROFEMUR NECK 15DG A/R LONG PHA01252 PROFEMUR NECK 8DG VAR/VAL SHORT PHA01254 PROFEMUR NECK 8DG VAR/VAL LONG PHA01256 PROFEMUR NECK 8DG VAR/VAL X LONG PHA01262 PROFEMUR NECK 15DG VAR/VAL SHORT PHA01264 PROFEMUR NECK 15DG VAR/VAL LONG Intended Use: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.Class II·Ongoing·MicroPort Orthopedics Inc.·20200731
• Z-2743-2015 — PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.Class I·Terminated·MicroPort Orthopedics, Inc.·20150804

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091423.