# K962789: Surgical Kit-Acufex Mosaicplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Aug 14, 1996 after 28 days
- Product code: GEY (Motor, Surgical Instrument, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Drill Guide (Synthes): named in the summary without a submission number
- (no number) Drill Sleeves (Synthes): named in the summary without a submission number
- (no number) Drill Bits (Synthes): named in the summary without a submission number
- (no number) Gouges (Synthes): named in the summary without a submission number
- (no number) Trephine Drills (Smith & Nephew Endoscopy): named in the summary without a submission number
- (no number) Tamps (Zimmer): named in the summary without a submission number
- (no number) Bone Grafter Instrument (Makar): named in the summary without a submission number
- (no number) Quick Coupling Adapter (Quick Coupling, Power) (Synthes): named in the summary without a submission number
- (no number) Bone Compression Forceps (KMedic): named in the summary without a submission number

## Indications for use
The components of the MosaicPlasty System are intended to be used for drilling bone, harvesting osteochondral bone grafts and transferring grafts to the drilled site.

Source page: https://510kreport.com/device/K962789
Methodology: https://510kreport.com/methodology