510(k) Report

510(k) · Cleared

Cleared

Surgical Kit-Acufex Mosaicplasty System

K962789510(k) TraditionalCleared Aug 14, 199628-day reviewClass I21 CFR 878.4820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew Endoscopy, Inc. · GEY Motor, Surgical Instrument, Ac-Powered

Cleared on Aug 14, 1996 after a 28-day review. The FDA summary names its predicate without a number.

Decided
Aug 14, 1996
Review
28 days
Class
Class I
Product code
GEY
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K962789Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (9)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Drill Guide (Synthes)
Named without a submission number
—
*—Drill Sleeves (Synthes)
Named without a submission number
—
*—Drill Bits (Synthes)
Named without a submission number
—
*—Gouges (Synthes)
Named without a submission number
—
*—Trephine Drills (Smith & Nephew Endoscopy)
Named without a submission number
—
*—Tamps (Zimmer)
Named without a submission number
—
*—Bone Grafter Instrument (Makar)
Named without a submission number
—
*—Quick Coupling Adapter (Quick Coupling, Power) (Synthes)
Named without a submission number
—
*—Bone Compression Forceps (KMedic)
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GEY devices

GEY Motor, Surgical Instrument, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEY

FDA has decided no GEY device since 2007.

Median 510(k) review, days · GEY

Too few GEY 510(k)s in any year since 2007 to give a median.

Recalls per year · GEY

2in 2013

2008: 12009: 12012: 12013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEY

965in 2025

2007: 192008: 92009: 42010: 42011: 112012: 142013: 9012014: 7382015: 2,0132016: 1,9432017: 2,1192018: 1,2882019: 1,1312020: 9522021: 1,1452022: 1,3602023: 1,4442024: 1,4472025: 965
2007high 2,119 (2017) · low 4 (2009)2025

MAUDE reports naming product code GEY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—019
20080—19
20090—14
20100—04
20110—011
20120—114
20130—2901
20140—0738
20150—02,013
20160—01,943
20170—02,119
20180—01,288
20190—01,131
20200—0952
20210—01,145
20220—01,360
20230—01,444
20240—01,447
20250—0965
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Smith & Nephew Endoscopy, Inc.

18 FDA decisions under this applicant name. See the company

  • K103309Osteoraptor Curved 2.3 Suture AnchorsSmith & Nephew Endoscopy, Inc. · 2011
  • K102660Bioraptor Curved 2.3 PK Suture AnchorsSmith & Nephew Endoscopy, Inc. · 2010
  • K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
  • K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
  • K083226Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009

Recent decisions in GEY

The GEY category page

  • K050519Advanced Turbo Drive SystemLinvatec Corp. · 20052 recalls
  • K020621Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp. · 2002
  • K012738Symphony Graft Delivery System (GDS)Depuyacromed · 2001
  • K972308Mednext 1000 DrillMednext, Inc. · 1997
  • K971941Aqua SprayBoyd Industries, Inc. · 1997

https://510kreport.com/device/K962789 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962789: Surgical Kit-Acufex Mosaicplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962789

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026