# K983014: Summit Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Oct 27, 1998 after 60 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 K930712 (1993). 5 ancestors in all.
404 later devices descend from it; 2 cite it directly.
0 of 410 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951000: ZTT I and II Acetabular Cup of the S-Rom Total Hip System, Joint Medical Products Corp. (1995) Summary page 2.
- K955511: Arthopor I & II Acetabular Cup/Arthopor II Oblong  Acetabular Cup, Joint Medical Products Corp. (1996) Summary page 2.
- K931189: P.F.C. Total Hip System Porous Coated Modular Acet, Johnson & Johnson Orthopaedics, Inc. (1994) Summary page 2.
- K930712: P.F.C. Total Hip System Porous Coated Modular, Johnson & Johnson Orthopaedics, Inc. (1993) Summary page 2.
- K951301: Depuy Duraloc Cementless Acetabular Cup System, Depuy, Inc. (1995) Summary page 2.

## Most influential descendants
- K000306: Pinnacle Acetabular System (2000), 403 descendants of its own
- K001534: Pinnacle Acetabular System (2000), 267 descendants of its own
- K031110: Apex Modular Acetabular Cup (2003), 217 descendants of its own
- K031495: Pinnacle Duofix HA Acetabular Cup Prosthesis (2003), 207 descendants of its own
- K042344: Excia Total Hip System (2005), 198 descendants of its own

## Indications for use
The SUMMIT™ Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. All SUMMIT™ porous-coated acetabular shells are indicated for cementless application.

Source page: https://510kreport.com/device/K983014
Methodology: https://510kreport.com/methodology