# K092098: Patient Specific Acetabular Reconstruction Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 22, 2010 after 192 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: 4 generations back to K861766 (1986). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962541: Reflection Acetabular Reinforcement Rings, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- K040680: Contour HA Coated Reconstruction Ring, Smith & Nephew, Inc. (2004) Summary page 1.
- K061253: Reflection 3 Acetabular System, Smith & Nephew, Inc. (2006) Summary page 1.
- K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 1.
- K932755: Reflection Acetabular Component, Smith & Nephew Richards, Inc. (1994) Summary page 1.
- K990666: Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit Shell, Smith & Nephew, Inc. (1999) Summary page 1.
- K060630: Reflection 3-Hole Shell with Asymmetric Porous Coating, Smith & Nephew, Inc. (2006) Summary page 1.
- K983035: Custom Flanged Acetabular Component, Biomet, Inc. (1998) Summary page 1.
- K030861: HA Pmi Flanged Acetabular Component, Biomet, Inc. (2003) Summary page 1.
- K973119: Foundation Porous Acetabular System, Encore Orthopedics, Inc. (1998) Summary page 1.

## Most influential descendants
- K123598: Smith & Nephew, Inc. Hip System Instrumentation (2013), 0 descendants of its own

## Indications for use
The Patient Specific Acetabular Reconstruction Prosthesis is intended to be used in primary and revision surgeries where the acetabulum has deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed below. The device is for single use and is intended for cementless application. The Patient Specific Acetabular Reconstruction Prosthesis is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endloprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip and diastrophic variant.

Source page: https://510kreport.com/device/K092098
Methodology: https://510kreport.com/methodology