510(k) Report

510(k) · Cleared

Cleared

Circular Fixation with Balanced Cable Transport

K202762510(k) TraditionalCleared Nov 16, 202056-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. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Nov 16, 2020 as substantially equivalent to K042436 (Smith & Nephew, Inc., 2004) after a 56-day review. Its family tree reaches back 2 generations to 1987.

Decided
Nov 16, 2020
Review
56 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K870961 (1987). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK870961 · Richards External Fixation System · Richards Medical Co., Inc. · 1987K042436 · Iiizarov Pulley System · Smith & Nephew, Inc. · 20041990200020102020
Other ancestors, by generation 2 generations back: 1 other ancestor K042436 · Iiizarov Pulley System · Smith & Nephew, Inc. · 2004K870961 · Richards External Fixation System · Richards Medical Co., Inc. · 19870
  1. Root · 2 generations backK870961 Richards External Fixation SystemRichards Medical Co., Inc. · 1987
  2. 1 generation backK042436 Iiizarov Pulley SystemSmith & Nephew, Inc. · 2004
  3. This deviceK202762 Circular Fixation with Balanced Cable TransportSmith & Nephew, Inc. · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K870961Richards External Fixation SystemRichards Medical Co., Inc.1987—
−1K042436Iiizarov Pulley SystemSmith & Nephew, Inc.2004—
0 (this device)K202762Circular Fixation with Balanced Cable TransportSmith & Nephew, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K202762, 1987–2020Source: FDA 510(k) summaries, read by 510(k) Report · 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 14 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? (1)

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
*K042436Iiizarov Pulley System
Summary page 4
…ce Class: Class II Panel Code: Orthopedic/87 Product Code: KTT Predicate Device: ILIZAROV Pulley System – K042436 The predicate device has not been subject to a design related recall.…
Smith & Nephew, Inc.2004—

Also cleared against K042436: 2 other devices →

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.

What does this lineage say?

  • The line of descent spans 33 years and passes through 2 companies; a new generation was cleared every 17.6 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K042436.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

External fixation devices are used on adults or pediatric patients as required. External fixation systems consist of various components that are used to build fixator assemblies unique to the patient’s needs. These devices are modular therefore, a multitude of different fixator frame configurations are possible. External fixation devices are used for the following indications: 1. Fractures and disease which generally may result in joint contractures or…

Read the full statement (167 words)

External fixation devices are used on adults or pediatric patients as required. External fixation systems consist of various components that are used to build fixator assemblies unique to the patient’s needs. These devices are modular therefore, a multitude of different fixator frame configurations are possible. External fixation devices are used for the following indications:

1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction

2. Open and closed fracture fixation

3. Pseudoarthrosis of long bones

4. Limb lengthening by distraction (not applicable for use with

COMPASS Universal Hinge)

5. Correction of bony or soft tissue deformities (not applicable for use with COMPASS Universal Hinge).

6. Joint arthrodesis (not applicable for use with COMPASS Universal Hinge)

7. Infected fractures

8. Nonunions

The indications for use listed above cover many of the external fixation systems marketed by Smith & Nephew. These indications are similar to the indications of the predicate devices. The device is intended for single use.

Indications for use as stated in the FDA summary.

Also cleared against K042436

2 other devices cite the same predicate.

  • K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other…Smith & Nephew · 2020
  • K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012

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 KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K202762 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202762: Circular Fixation with Balanced Cable Transport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202762

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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