# K994038: Modular Reach Hip

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Dec 22, 1999 after 23 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: 1 generation back to K921274 (1994). 1 ancestor in all.
43 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921274: Metallic Toatal Hip System, Biomet, Inc. (1994) Summary page 1.

## Most influential descendants
- K022463: HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral Stems (2002), 42 descendants of its own
- K031693: Mallory/Head  Modular Calcar with and Without HA (2003), 39 descendants of its own
- K042774: Mallory-Head Modular Calcar Stems with Interlocking Slots (2005), 38 descendants of its own
- K090757: Biomet Modular Femoral Revision System (2009), 37 descendants of its own
- K092331: Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110; (2010), 27 descendants of its own

## Indications for use
1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatment or devices have failed; 5) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Source page: https://510kreport.com/device/K994038
Methodology: https://510kreport.com/methodology