# K960094: Reflection Dual Dimension Shell

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Mar 27, 1996 after 76 days
- Product code: MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous)
- 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
No predicates in its family tree.
18 later devices descend from it; 3 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Osteonics PSL: named in the summary without a submission number
- (no number) DePuy Duraloc: named in the summary without a submission number

## Most influential descendants
- K112898: Delta TT Cups, Delta TT Liners, Bone Screws (2012), 12 descendants of its own
- K141395: Delta TT Acetabular System (2014), 10 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K182099: Delta TT Pro (2018), 3 descendants of its own
- K191622: Delta Multihole TT Pro Acetabular System (2019), 2 descendants of its own

## Recalls of this device
- Jan 23, 2014 · Class II · Z-1066-2014: Inner spherical radius of the shell is undersized.

## Indications for use
The indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; avascular necrosis; femoral neck fractures; osteomyelitis; fracture-dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.

Source page: https://510kreport.com/device/K960094
Methodology: https://510kreport.com/methodology