# K061253: Reflection 3 Acetabular System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: May 31, 2006 after 27 days
- Product code: MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous)
- 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: 2 generations back to K861766 (1986). 7 ancestors in all.
120 later devices descend from it; 11 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920430: Modular Acetabular Cup System, Smith & Nephew Richards, Inc. (1992) 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.
- K964094: Minifix, Ferguson Medical (1996)
- K002747: Reflection Cross-Linked Uhmwpe Acetabular Components, Smith & Nephew, Inc. (2000) Summary page 2.

## Most influential descendants
- K070756: Smith and Nephew Reflection 3 Acetabular System (2007), 91 descendants of its own
- K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners (2009), 46 descendants of its own
- K100933: Consensus CS2 Plus Acetabular Insert (2010), 35 descendants of its own
- K102399: Consensus Taperset Hip System (2010), 33 descendants of its own
- K100445: Klassic HD Hip System (2010), 25 descendants of its own

## Indications for use
The REFLECTION 3 Acetabular System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammator joint disease such as rheumatoidathritis, or noninflammatory degenerative joint disease (NIDJD] or any of its composite diagnoses such as osteoarthritis: avasular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyetitis with an extended drainage-free period; non-union; femnoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteolomy; or Girdlestone resection: fracture dislocation of the hip; and correction of deformity. The REFLECTION 3 Acetabular System is for single use only. The REFLECTION 3 Acetabutar System is intended for cementless use.

Source page: https://510kreport.com/device/K061253
Methodology: https://510kreport.com/methodology