# K993352: Crossfire System 12 Acetabular Inserts

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 19, 1999 after 45 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 K903362 (1990). 6 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974685: Osteonics Polyethylene Acetabular Components, Osteonics Corp. (1998) Summary page 1.
- K903362: Osteolock (TM) Acetabular Cup, Howmedica Corp. (1990) Summary page 2.
- K951114: System 12 P1 26MM Acetabular Insert, Howmedica Corp. (1995) Summary page 2.
- K951115: Howmedica Vitalock 22MM Acertabular Shell and System 12 Inserts, Howmedica Corp. (1995) Summary page 2.
- K934060: Howmedica (R) Acetabular Comp Pack/Manuf Meth Change, Howmedica Corp. (1995) Summary page 2.
- K963612: Duration Stabilized Uhmwpe, Howmedica Corp. (1997) Summary page 2.

## Most influential descendants
- K111546: U2 Hip System (2011), 13 descendants of its own
- K122185: U-Motion II Acetabular System (2013), 7 descendants of its own
- K163441: Locking Cage, Full XPE Cup (2017), 3 descendants of its own
- K132455: U-Motion II PS+ Cup (2013), 3 descendants of its own
- K122504: Femoral Heads, 2.5 and 7.5 MM Neck Length (2012), 3 descendants of its own

## Indications for use
The subject devices are single use components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows: . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, . rheumatoid arthritis, . correction of functional deformity, . revision procedures where other treatments or devices have failed, and . treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K993352
Methodology: https://510kreport.com/methodology