# K251270: Taperloc® Complete Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 19, 2026 after 390 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K850055 (1985). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120030: Taperloc Complete Size 4MM and XR 123, Biomet Manufacturing Corp (2012) Summary page 5.
- K200196: Taperloc® Complete Hip Stems, Biomet Orthopedics (2020) Summary page 5.
- K110400: Taperloc Complete Microplasty Stem, Biomet Manufacturing Corp (2011) Summary page 5.
- K103755: Taperloc Complete, Size 5 and 6, Biomet Manufacturing Corp (2011) Summary page 5.

## Indications for use
Biomet Taperloc Complete stems are porous coated femoral stems intended for uncemented biological fixation. They are offered in various sizes and offsets, as well as standard full-length and shortened Microplasty® stem lengths. BoneMaster™ HA coated stems, the only available HA coating for Taperloc Complete stems, are for sale outside the United States only. The Taperloc Complete hip stems can be used for either total or hemi hip arthroplasty. INDICATIONS 1. Noninflammatory 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/K251270
Methodology: https://510kreport.com/methodology