510(k) Report

510(k) · Cleared

Cleared

Knee Fusion Nail

K061783510(k) TraditionalCleared Aug 10, 200645-day reviewClass II21 CFR 888.3030

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

Smith & Nephew, Inc. · JDS Nail, Fixation, Bone

Cleared on Aug 10, 2006 as substantially equivalent to K050938 (Smith & Nephew, Inc., 2005) and 3 other predicates after a 45-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.

Decided
Aug 10, 2006
Review
45 days
Class
Class II
Product code
JDS
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K893377 (1989). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 2 other ancestors2012: 1 descendant clearedK893377 · Russell-Taylor Intramedullary Knee Fusion Nails · Richards Medical Co., Inc. · 1989K050938 · Knee Fusion Nail · Smith & Nephew, Inc. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K050938 · Knee Fusion Nail · Smith & Nephew, Inc. · 2005K893377 · Russell-Taylor Intramedullary Knee Fusion Nails · Richards Medical Co., Inc. · 19890
  1. Root · 2 generations backK893377 Russell-Taylor Intramedullary Knee Fusion NailsRichards Medical Co., Inc. · 1989
  2. 1 generation backK050938 Knee Fusion NailSmith & Nephew, Inc. · 2005
  3. This deviceK061783 Knee Fusion NailSmith & Nephew, Inc. · 2006
  4. Descendant · cites it directly · 0 of its ownK122170 Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K893377Russell-Taylor Intramedullary Knee Fusion NailsRichards Medical Co., Inc.1989—
−1K050938Knee Fusion NailSmith & Nephew, Inc.2005—
0 (this device)K061783Knee Fusion NailSmith & Nephew, Inc.2006—
+1K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.20121

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K061783, 1989–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Top candidate predicates for a new JDS device

  1. #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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
*K050938Knee Fusion Nail
Summary page 1
…nee arthrodesis. Device Comparison to Legally Marketed Devices The Knee Fusion Nail issubstantially equivalent to the Smith & Nephew Knee Fusion Nail included in 510(k) K050938 based on intended use and design features. The subject nail isStainless Steel, similar to predicate nails in 510(k)s K893377 and…
Smith & Nephew, Inc.2005—
*K893377Russell-Taylor Intramedullary Knee Fusion Nails
Summary page 1
…& Nephew Knee Fusion Nail included in 510(k) K050938 based on intended use and design features. The subject nail isStainless Steel, similar to predicate nails in 510(k)s K893377 and K983942. The Knee Fusion Nail is substantially equivalent to the Smith & Nephew Intramedullary Knee Fusion Nails included in…
Richards Medical Co., Inc.1989—
*K983942Intramedullary Nail System, Locking Screw, Nail Cap
Summary page 1
…features holes/slots on both ends of the nail for optional locking screws. The nails and screws are made of Stainless Steel. The screws were previously cleared in 510(k) K983942. Intended Use The Knee Fusion Nail is intended for intramedullary knee arthrodesis. Device Comparison to Legally Marketed Devic…
Smith & Nephew, Inc.1998—
*K981529Titanium Intramedullary Nail, Titanium Locking Screw
Summary page 1
…510(k)s K893377 and K983942 based on intended use and material. The Knee Fusion Nail is substantially equivalent to the Smith & Nephew Titanium Nails included in510(k) K981529 based on design features such as screw hole/slot configuration. The predicate nails are made of Titanium, available in shorter le…
Smith & Nephew, Inc.19982

Also cleared against K050938: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.20120

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.

What does this lineage say?

  • The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 15.5 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K122170 (Smith & Nephew, Inc., 2012) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K050938.

How does its category compare?

All JDS devices

JDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDS

1in 2025

2007: 22008: 12011: 12013: 12015: 12020: 32023: 12024: 32025: 1
2007high 3 (2020) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDS

146in 2024

2020: 106 days median2024: 146 days median
2007high 146 (2024) · low 106 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JDS

2in 2025

2009: 32010: 22013: 42017: 12020: 12025: 2
2007high 4 (2013) · low 0 (2007)2026

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

Adverse event reports per year · JDS

497in 2025

2007: 1612008: 1692009: 1602010: 702011: 1042012: 1952013: 2842014: 3882015: 3162016: 5062017: 2872018: 3202019: 4902020: 6432021: 6302022: 5892023: 3572024: 4662025: 497
2007high 643 (2020) · low 70 (2010)2025

MAUDE reports naming product code JDS, 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
20072—0161
20081—0169
20090—3160
20100—270
20111—0104
20120—0195
20131—4284
20140—0388
20151—0316
20160—0506
20170—1287
20180—0320
20190—0490
202031061643
20210—0630
20220—0589
20231—0357
202431460466
20251—2497
20260—0—

What is it indicated for?

Knee Fusion Nails are intended for intramedullary knee arthrodesis.

Indications for use as stated in the FDA summary.

Also cleared against K050938

3 other devices cite the same predicate.

  • K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc. · 20224 recalls
  • K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 20121 recall
  • K101939Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH · 20101 recall

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in JDS

The JDS category page

  • K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025
  • K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc. · 2024
  • K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc. · 2024
  • K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical, Ltd. · 2024
  • K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc. · 2023

https://510kreport.com/device/K061783 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061783: Knee Fusion Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061783

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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