# K090757: Biomet Modular Femoral Revision System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 25, 2009 after 186 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921308 (1994). 24 ancestors in all.
37 later devices descend from it; 7 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031693: Mallory/Head  Modular Calcar with and Without HA, Biomet, Inc. (2003) Summary page 2.
- K042774: Mallory-Head Modular Calcar Stems with Interlocking Slots, Biomet, Inc. (2005) Summary page 2.
- K013106: 2 Piece Modular Hip Stem, Howmedica Osteonics Corp. (2002) Summary page 2.
- K022549: Restoration Modular System, Howmedica Osteonics Corp. (2002) Summary page 2.
- K994038: Modular Reach Hip, Biomet, Inc. (1999) Summary page 2.

## Most influential descendants
- K092331: Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110; (2010), 27 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K151739: Revision Femoral Stem (2015), 7 descendants of its own
- K100469: Arcos Interlocking Distal Stems (2010), 7 descendants of its own
- K170690: M-Vizion Femoral Revision System (2017), 5 descendants of its own

## Recalls of this device
- Jun 2, 2021 · Class II · Z-2264-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2274-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2262-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2273-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2268-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2275-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2272-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2267-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2266-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2269-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2259-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2260-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2265-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2270-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2271-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2263-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 2, 2021 · Class II · Z-2261-2021: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Jun 8, 2018 · Class II · Z-2820-2018: Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

## Indications for use
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 using other techniques. 5. Revision of previously failed total hip arthroplasty. The Biomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.

Source page: https://510kreport.com/device/K090757
Methodology: https://510kreport.com/methodology