510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Smith & Nephew Circular Fixation System

K093047510(k) TraditionalCleared Sep 27, 2010362-day reviewClass II21 CFR 888.3030Recalls 1

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 Sep 27, 2010 as substantially equivalent to K870961 (Richards Medical Co., Inc., 1987) and 5 other predicates after a 362-day review. Its family tree reaches back 9 generations to 1996. 51 later devices descend from it. It has been recalled once.

Decided
Sep 27, 2010
Review
362 days
Class
Class II
Product code
KTT
Recalls
1
Predicates
6

Its longest line of descent runs back 9 generations to K962616 (1996). 51 ancestors in all, the oldest K792022 (1979). 51 later devices descend from it, 13 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2000: 7 other ancestors1997: 1 other ancestor1996: 4 other ancestors1987: 1 other ancestor2006: 3 other ancestors2005: 2 other ancestors2003: 1 other ancestor2001: 6 other ancestors1999: 2 other ancestors1990: 1 other ancestor2004: 3 other ancestors2002: 1 other ancestor1998: 2 other ancestors1994: 1 other ancestor1993: 2 other ancestors1979: 1 other ancestor1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2016: 2 descendants cleared2012: 1 descendant cleared2019: 3 descendants cleared2020: 4 descendants cleared2021: 6 descendants cleared2013: 1 descendant cleared2014: 4 descendants cleared2011: 1 descendant cleared2018: 4 descendants cleared2026: 6 descendants cleared2023: 3 descendants cleared2025: 8 descendants cleared2022: 2 descendants cleared2024: 3 descendants cleared2015: 1 descendant cleared2017: 2 descendants clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 6 other ancestors3 generations back: 12 other ancestors4 generations back: 12 other ancestors5 generations back: 5 other ancestors8 generations back: 1 other ancestor9 generations back: 1 other ancestor 1 generation forward: 13 descendants2 generations forward: 19 descendants3 generations forward: 6 descendants4 generations forward: 5 descendants5 generations forward: 5 descendants6 generations forward: 3 descendants K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−50+5
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 5 generations between
  3. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  4. 2 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  5. 1 generation backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  6. This deviceK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010
  7. Descendant · cites it directly · 32 of its ownK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
  8. Descendant · 2 generations on · 26 of its ownK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
  9. Descendant · 3 generations on · 19 of its ownK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
  10. Descendant · cites it directly · 18 of its ownK110069 Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011
  11. Descendant · 4 generations on · 11 of its ownK170650 Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl · 2017 · Recalled
Show all 9 generations
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 2 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 1 generation backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. This deviceK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12013: 12014: 42015: 12016: 22017: 22018: 42019: 32020: 42021: 62022: 22023: 32024: 32025: 82026: 6
2011high 8 (2025) · low 1 (2011)2026

Most influential descendants

Showing 5 of 51 · See all
  • K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014 · cites it directly32descendants
  • K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014 · 2 generations on26descendants
  • K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015 · 3 generations on19descendants
  • K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011 · cites it directly18descendants
  • K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl · 2017 · 4 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−8K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−7K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−6K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−5K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−4K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−3K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−2K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−1K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
0 (this device)K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010—
+1K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl2014—
+2K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl2014—
+3K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl2015—
+1K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.2011—
+4K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl20171

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198710
198910
199010
199110
199320
199410
199510
199640
199710
199820
199920
200070
200160
200210
200310
200430
200520
200630
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201310
201440
201510
201620
201720
201840
201930
202040
202160
202220
202330
202430
202580
202660
FIG. 1 — Lineage of K093047, 1996–2026Source: 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? (6)

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
*K870961Richards External Fixation System
Summary page 2
…Description Sumbmisio Clearance Date Smith & Nephew llizarov (Richards) External Fixation K870961 03-19-1987 ____ ____ ____ ___ System Smith & Nephew lllizarov Ektern…
Richards Medical Co., Inc.1987—
*K962808Ilizarov External Fixation System
Summary page 2
…K870961 03-19-1987 ____ ____ ____ ___ System Smith & Nephew lllizarov Ekternal Fixation System K962808 08-19-1996 Smith & Nephew Taylor Spatial Frame K970748…
Smith & Nephew Richards, Inc.1996—
*K970748Taylor Spatial Frame External Fixation System
Summary page 2
…lllizarov Ekternal Fixation System K962808 08-19-1996 Smith & Nephew Taylor Spatial Frame K970748 05-09-1997 Smith & Nephew External Fixation System K994143…
Smith & Nephew, Inc., Orthopaedic Div.1997—
*K994143Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…
Summary page 2
…Taylor Spatial Frame K970748 05-09-1997 Smith & Nephew External Fixation System K994143 02-18-2000 Smith & Nephew Jet-X Bar System Clamps, Bar and K072212…
Smith & Nephew, Inc.200019
*K072212Jet-X Bar System Clamps, Bars and Posts-MR Safe
Summary page 2
…External Fixation System K994143 02-18-2000 Smith & Nephew Jet-X Bar System Clamps, Bar and K072212 03-07-2008 Posts Smith & Nephew VLP Foot Plating. Screw system…
Smith & Nephew, Inc.2008—
*K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories
Summary page 2
…K072212 03-07-2008 Posts Smith & Nephew VLP Foot Plating. Screw system and K090675 06-04-2009 Accessories _ _ _ _ _ _ _…
Smith & Nephew, Inc.2009—

Also cleared against K870961: 9 other devices →

What descends from it? (51)

See all 51

13 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432
K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118
K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168
K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.20167
K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136
K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126
K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205
K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145
K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184
K193368Smart Correction SystemWishbone Medical, Inc.20203

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 17, 2021Class IIZ-0245-2022Process controlMedicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • 14 of the 51 ancestors have a recall of any class.
  • Of its descendants, K141078 (Orthofix Srl, 2014) has gone furthest, with 32 descendants of its own.
  • 9 other devices also cite its predicate K870961.

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. 2010, 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?

The Smith & Nephew Circular Fixation system is intended to be used for the following indications:

* Post-traumatic joint contracture which has resulted in loss of range of motion

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

* Open and closed fracture fixation

* Pseudoarthrosis of long bones

* Limb lengthening by epiphyseal or metaphyseal distraction

* Correction of bony or soft tissue deformities

* Correction of bony or soft tissue defects

* Joint arthrodesis

* Infected fractures or nonunions

Components in the Smith & Nephew Circular Fixation System are for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K870961

9 other devices cite the same predicate.

  • K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC · 2019
  • K151881X-Fix Line AdditionsVilex IN Tennessee, Inc. · 20162 recalls
  • K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc. · 2013
  • K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
  • K093753Mdpo Frame SystemMdpo, LLC · 2010
  • K042436Iiizarov Pulley SystemSmith & Nephew, Inc. · 2004

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/K093047 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093047: Smith & Nephew Circular Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093047

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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