# K023357: Arcpm 1050 Resin-Hips

- Pathway: 510(k) (Special)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Nov 6, 2002 after 30 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920639 (1992). 7 ancestors in all.
480 later devices descend from it; 5 cite it directly.
0 of 488 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950761: Index Acetabulat Component, Biomet, Inc. (1995) Summary page 8.
- K954417: A-B Acetabular Component, Biomet, Inc. (1995) Summary page 8.
- K920639: RX 90 Acetabular Component System, Biomet, Inc. (1992) Summary page 9.
- K920640: Full Hemisphere Ring-Loc Liner, Biomet, Inc. (1992) Summary page 2.
- K926107: Arcom Polyethylene Acetabular Liners & Components, Biomet, Inc. (1993) Summary page 9.
- K921274: Metallic Toatal Hip System, Biomet, Inc. (1994) Summary page 2.
- K970501: Pegged Acetabular Component, Biomet, Inc. (1997) Summary page 11.

## Most influential descendants
- K042051: Arcomxl Polyethylene Liners (2005), 355 descendants of its own
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads (2005), 344 descendants of its own
- K061312: 36MM Biolox Delta Ceramic Heads (2006), 343 descendants of its own
- K050327: E-Poly (Vitamin E) Acetabular Liners (2005), 289 descendants of its own
- K070364: 100KGY E-Poly Maxrom Acetabular Liners (2007), 286 descendants of its own

## Recalls of this device
- Feb 17, 2017 · Class II · Z-1860-2017: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

## Indications for use
The products found in the original 510(k) K950761, and K954417 will use the following 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 treatments or devices have failed and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. For Cemented and Non-cemented use The products found in the original 510(k) K920639, K920640 and K926107 will use the following 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 treatments or devices have failed and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. For Cemented use only The products found in the original 510(k) K921274 will use the following 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 treatments or devices have failed and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. For Non-Cemented use only The products found in the original 510(k) K970501 will use the following Indications for Use: Intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant

Source page: https://510kreport.com/device/K023357
Methodology: https://510kreport.com/methodology