510(k) Report

510(k) · Cleared

Cleared

Knee Prosthesis Driver

K915776510(k) TraditionalCleared Jun 11, 1992170-day reviewClass I21 CFR 888.4540

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

Kim-Med, Inc. · HWR Driver, Prosthesis

Cleared on Jun 11, 1992 after a 170-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jun 11, 1992
Review
170 days
Class
Class I
Product code
HWR
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K915776Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HWR? 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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 HWR devices

HWR Driver, Prosthesis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWR

FDA has decided no HWR device since 2007.

Median 510(k) review, days · HWR

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

Recalls per year · HWR

1in 2013

2007: 22010: 12013: 1
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · HWR

1,210in 2025

2007: 12008: 12009: 32010: 12011: 92012: 92013: 132014: 22015: 1922016: 4362017: 7072018: 5742019: 6782020: 7382021: 8982022: 9792023: 1,2802024: 1,2112025: 1,210
2007high 1,280 (2023) · low 1 (2007)2025

MAUDE reports naming product code HWR, 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—21
20080—01
20090—03
20100—11
20110—09
20120—09
20130—113
20140—02
20150—0192
20160—0436
20170—0707
20180—0574
20190—0678
20200—0738
20210—0898
20220—0979
20230—01,280
20240—01,211
20250—01,210
20260—0—

Recent decisions in HWR

The HWR category page

  • K875054Acromed Ads Bone Nail DriverBuckman Co., Inc. · 1988
  • K870848Schultz Metacarpal Component DriverWarsaw Orthopedic, Inc. · 1987
  • K870847Schultz Phalangeal Component DriverWarsaw Orthopedic, Inc. · 1987

https://510kreport.com/device/K915776 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915776: Knee Prosthesis Driver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915776

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026