# K964215: Acufex Mosaicplasty Comprehensive System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Dec 20, 1996 after 59 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) 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) 2.7 mm Arthr. Drill (Synthes): named in the summary without a submission number
- (no number) Arthr. Reamer Drills: 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) Arthr. Transfer Tubes (Makar®): named in the summary without a submission number
- (no number) Quick Coupling Adapter (Synthes): named in the summary without a submission number
- (no number) Bone Compression Forceps (KMedic®): named in the summary without a submission number
- (no number) Metal Cannula (Smith & Nephew Endoscopy): named in the summary without a submission number

## Most influential descendants
- K051656: Oct (Osteochondral Transplant) Comprehensive System (2005), 0 descendants of its own

## Recalls of this device
- Sep 10, 2015 · Class II · Z-0158-2016: Sterility of device is compromised due to breach in the packaging
- Sep 10, 2015 · Class II · Z-0155-2016: Sterility of device is compromised due to breach in the packaging
- Sep 10, 2015 · Class II · Z-0156-2016: Sterility of device is compromised due to breach in the packaging
- Sep 10, 2015 · Class II · Z-0157-2016: Sterility of device is compromised due to breach in the packaging

## Indications for use
The Acufex® MosaicPlasty™ Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.

Source page: https://510kreport.com/device/K964215
Methodology: https://510kreport.com/methodology