# K191632: PROFEMUR TL2 Stems

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Oct 7, 2019 after 110 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: 2 generations back to K060358 (2006). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123688: Profemur TL Classic Hip Stem, Wrightmedicaltechnologyinc (2013) Summary page 4.

## Most influential descendants
- K250444: NEXUS® Hip Stem (2025), 0 descendants of its own
- K213816: MPO Hip Instruments (2022), 0 descendants of its own

## Indications for use
PROFEMUR® TL2 stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed Titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.

Source page: https://510kreport.com/device/K191632
Methodology: https://510kreport.com/methodology