# K200196: Taperloc® Complete Hip Stems

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics
- Decided: Dec 8, 2020 after 316 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K101086 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101086: Taperloc Complete, Biomet, Inc. (2010) Summary page 5.

## Most influential descendants
- K251270: Taperloc® Complete Hip Stem (2026), 0 descendants of its own

## Indications for use
1. Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union. Femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Porous coated components are intended for uncemented biological fixation.

Source page: https://510kreport.com/device/K200196
Methodology: https://510kreport.com/methodology