# K100866: Profemur Hip System Modular Necks

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Apr 28, 2010 after 30 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: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K893685 (1989). 3 ancestors in all.
14 later devices descend from it; 4 cite it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091423: Profemur Hip System Modular Necks, Wrightmedicaltechnologyinc (2009) Summary page 1.
- K081090: Profemur LX 5/8 Coated Hip Stem, Wrightmedicaltechnologyinc (2008)
- K893685: Ceramic Femoral Head, Dow Corning Wright (1989) Summary page 1.

## Most influential descendants
- K112080: Preserve Hip Stem (2011), 8 descendants of its own
- K111910: Gladiator Hip Stem (2011), 5 descendants of its own
- K150302: PROFEMUR Preserve Classic Stem (2015), 4 descendants of its own
- K112150: Profemur Gladiator HA Hip Stem (2011), 4 descendants of its own
- K150133: PROFEMUR Preserve Size 1-3 Hip Stems (2015), 3 descendants of its own

## Recalls of this device
- Jul 31, 2020 · Class II · Z-2948-2020: MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR¿ Hip Syst
- Jun 21, 2016 · Class III · Z-0683-2017: Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was foun
- Jun 21, 2016 · Class III · Z-0684-2017: Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was foun
- Jun 21, 2016 · Class III · Z-0688-2017: Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was foun
- Jun 21, 2016 · Class III · Z-0687-2017: Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was foun
- Jun 21, 2016 · Class III · Z-0689-2017: Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was foun
- Jun 21, 2016 · Class III · Z-0685-2017: Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was foun
- Jun 21, 2016 · Class III · Z-0686-2017: Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was foun
- Aug 4, 2015 · Class I · Z-2743-2015: Unexpected rate of postoperative fractures resulting in the need for revision surgery.

## Indications for use
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 Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty.

Source page: https://510kreport.com/device/K100866
Methodology: https://510kreport.com/methodology