# K200112: Zimmer Hip Joint Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Apr 10, 2020 after 84 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921308 (1994). 118 ancestors in all.
No later device cites it as a predicate yet.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191781: Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System, Zimmer GmbH (2019) Summary page 11.
- K192416: BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System, Zimmer GmbH (2019) Summary page 11.
- K192236: Fitmore Hip Stem, Zimmer GmbH (2019) Summary page 11.
- K193030: Avenir Muller Stem, Avenir Cemented Hip Stem, Zimmer GmbH (2019) Summary page 12.
- K193050: Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem, Zimmer GmbH (2019) Summary page 12.

## Recalls of this device
- Nov 2, 2023 · Class II · Z-0570-2024: One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an ada
- Nov 2, 2023 · Class II · Z-0569-2024: One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an ada

## Indications for use
Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (1JD), e.g., rheumatoid arthritis. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of: Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR) Acute traumatic fracture of the femoral head or neck Avascular necrosis of the femoral head. Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists. Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. Acute traumatic fracture of the femoral head or neck. Avascular necrosis of the femoral head. Avenir® Miiller Stems are for cementless use only. The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity. Patients with acute femoral neck fractures. The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the operative extremity. Patients with acute neck fractures. This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions: Noninflammatory degenerative joint disease (NIDJD), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (1JD), e. g., rheumatoid arthritis. Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists. Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure. This stem is for uncemented use only. Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (1JD), e.g., rheumatoid arthritis. Failed previous surgery where pain, deformity, or dysfunction persists. Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. Revision of previously failed hip arthroplasty

Source page: https://510kreport.com/device/K200112
Methodology: https://510kreport.com/methodology