# K963313: Exactech All Poly Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Nov 14, 1996 after 84 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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) T.A.R.A. by DePuy: named in the summary without a submission number
- (no number) Dual Lock by DePuy: named in the summary without a submission number
- (no number) New England Baptist System by DePuy: named in the summary without a submission number
- (no number) Triad System by Johnson and Johnson: named in the summary without a submission number
- (no number) Modular Hip System by Richard: named in the summary without a submission number
- (no number) Spectron Total Hip System by Richards: named in the summary without a submission number

## Most influential descendants
- K121055: Mets Modular Total Femur (2012), 3 descendants of its own
- K133152: JTS Extendible Distal Femoral Implant (2014), 2 descendants of its own
- K140900: Patient Specific Smiles Total Knee Replacement (2015), 0 descendants of its own
- K140898: Patient Specific Distal Femoral (2015), 0 descendants of its own
- K121056: Mets Modular Proximal Femur (2012), 0 descendants of its own

## Recalls of this device
- Aug 11, 2022 · Class II · Z-1733-2022: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

## Indications for use
The Exactech All Polyethylene Acetabular Cup is indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, ankylosing spondylitis and/or posttraumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.

Source page: https://510kreport.com/device/K963313
Methodology: https://510kreport.com/methodology