510(k) Report

510(k) · Cleared

Cleared

Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation

K201253510(k) TraditionalCleared Dec 8, 2020211-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 · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Dec 8, 2020 as substantially equivalent to K090926 (Smith & Nephew, Inc., 2009) and 13 other predicates after a 211-day review. Its family tree reaches back 11 generations to 1996. 5 later devices descend from it.

Decided
Dec 8, 2020
Review
211 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
14

Its longest line of descent runs back 11 generations to K962616 (1996). 66 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2004: 6 other ancestors2003: 3 other ancestors2002: 2 other ancestors2000: 7 other ancestors1997: 3 other ancestors1995: 2 other ancestors1992: 1 other ancestor1996: 4 other ancestors1987: 1 other ancestor1980: 1 other ancestor2006: 3 other ancestors2005: 2 other ancestors2001: 6 other ancestors1999: 2 other ancestors1990: 1 other ancestor1998: 2 other ancestors1994: 1 other ancestor1993: 2 other ancestors1979: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2025: 3 descendants cleared2026: 1 descendant cleared2024: 1 descendant 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. · 2009K093047 · Smith & Nephew Circular Fixation System · Smith & Nephew, Inc. · 2010 · recalledK120871 · Smith & Nephew, Inc. External Fixation System Instrumentation · Smith & Nephew, Inc. · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 12 other ancestors2 generations back: 6 other ancestors3 generations back: 6 other ancestors4 generations back: 12 other ancestors5 generations back: 12 other ancestors6 generations back: 5 other ancestors9 generations back: 1 other ancestor10 generations back: 1 other ancestor 1 generation forward: 5 descendants K120871 · Smith & Nephew, Inc. External Fixation System Instrumentation · Smith & Nephew, Inc. · 2012K093047 · Smith & Nephew Circular Fixation System · Smith & Nephew, Inc. · 2010 · recalledK090675 · 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) · 1996−10−50
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 7 generations between
  3. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  4. 2 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
  5. 1 generation backK120871 Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
  6. This deviceK201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X…Smith & Nephew · 2020
  7. Descendant · cites it directly · 1 of its ownK241563 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
  8. Descendant · cites it directly · 0 of its ownK253291 Excelsior SystemBlue Ocean Global · 2026
  9. Descendant · cites it directly · 0 of its ownK253202 Hoffmann LRF SystemStryker GmbH · 2025
  10. Descendant · cites it directly · 0 of its ownK251128 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
  11. Descendant · cites it directly · 0 of its ownK241769 Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC · 2024
Show all 11 generations
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 2 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
  11. 1 generation backK120871 Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
  12. This deviceK201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X…Smith & Nephew · 2020

Most influential descendants

Showing 5 of 5 · See all
  • K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · cites it directly1descendant
  • K253291Excelsior SystemBlue Ocean Global · 2026 · cites it directly0descendants
  • K253202Hoffmann LRF SystemStryker GmbH · 2025 · cites it directly0descendants
  • K251128Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · cites it directly0descendants
  • K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−10K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−9K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−8K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−5K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−4K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−2K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.20101
−1K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.2012—
0 (this device)K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator…Smith & Nephew2020—
+1K241563Extremity Medical External Fixation SystemExtremity Medical, LLC2025—
+1K253291Excelsior SystemBlue Ocean Global2026—
+1K253202Hoffmann LRF SystemStryker GmbH2025—
+1K251128Extremity Medical External Fixation SystemExtremity Medical, LLC2025—
+1K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198710
198910
199010
199110
199210
199320
199410
199520
199640
199730
199820
199920
200070
200160
200220
200330
200460
200520
200630
200810
200910
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202530
202610
FIG. 1 — Lineage of K201253, 1996–2026Source: 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 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? (14)

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
*K090926Smith & Nephew Rail System
Summary page 11
…on Clearance Date Number Smith & Nephew, Smith & Nephew Rail K090926 6/8/2009 Inc. System K120871 6/7/2012 Table 5.2: Substantially Equivalen…
Smith & Nephew, Inc.2009—
*K120871Smith & Nephew, Inc. External Fixation System Instrumentation
Summary page 11
…Number Smith & Nephew, Smith & Nephew Rail K090926 6/8/2009 Inc. System K120871 6/7/2012 Table 5.2: Substantially Equivalent Predicates to the External Fixation Systems…
Smith & Nephew, Inc.2012—
*K023921Jet-X HA Coated Half Pins
Summary page 11
…on Clearance Date Number K023921 2/5/2003 Smith & Nephew, TAYLOR SPATIAL FRAME K994143 2/…
Smith & Nephew, Inc.200327
*K994143Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…
Summary page 11
…K023921 2/5/2003 Smith & Nephew, TAYLOR SPATIAL FRAME K994143 2/18/2000 Inc. External Fixator K093047 9/27/…
Smith & Nephew, Inc.200019
*K093047Smith & Nephew Circular Fixation System
Summary page 11
…K994143 2/18/2000 Inc. External Fixator K093047 9/27/2010 Table 5.3: Substantially Equivalent Predicates to the External Fixation Systems…
Smith & Nephew, Inc.20101
*K023134Jet-X Tin Coated Half Pins
Summary page 11
…on Clearance Date Number K023134 10/9/2002 K072212 3/7/2008 Smith & Nephew,…
Smith & Nephew, Inc.2002—
*K072212Jet-X Bar System Clamps, Bars and Posts-MR Safe
Summary page 11
…Number K023134 10/9/2002 K072212 3/7/2008 Smith & Nephew, JET-X Fixator K994143 2/18/2000 Inc.…
Smith & Nephew, Inc.2008—
*K042312Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe
Summary page 11
…3/7/2008 Smith & Nephew, JET-X Fixator K994143 2/18/2000 Inc. K042312 9/24/2004 K120871 6/7/2012 Table 5.4: Substantially Equivale…
Smith & Nephew, Inc.2004—
*K042436Iiizarov Pulley System
Summary page 11
…on Clearance Date Number K042436 10/7/2004 K920024 1/27/1992…
Smith & Nephew, Inc.2004—
*K920024Rihards Titanium Half Pin
Summary page 11
…Number K042436 10/7/2004 K920024 1/27/1992 K953397 10/31/1995…
Smith & Nephew Richards, Inc.1992—
*K953397Hex-Fix Field Fixator
Summary page 11
…K042436 10/7/2004 K920024 1/27/1992 K953397 10/31/1995 K970751 4/16/1997 Smith & Nephew, ILIZAROV Ex…
Smith & Nephew Richards, Inc.1995—
*K970751Heidelberg External Fixator
Summary page 11
…K920024 1/27/1992 K953397 10/31/1995 K970751 4/16/1997 Smith & Nephew, ILIZAROV External K994143 2/18…
Smith & Nephew, Inc., Orthopaedic Div.1997—
*K970713Compass Universal Hinge
Summary page 11
…K994143 2/18/2000 Inc. Fixator/System K970713 4/3/1997 K093047 9/27/2010…
Smith & Nephew, Inc., Orthopaedic Div.1997—
*K130479Ilizarov Drill Tip Wires
Summary page 11
…K093047 9/27/2010 K120871 6/7/2012 K130479 5/17/2013 Table 5.5: Substantially Equivalent Predicates to the External Fixation Systems…
Smith & Nephew, Inc.2013—

Also cleared against K090926: 2 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251
K253291Excelsior SystemBlue Ocean Global20260
K253202Hoffmann LRF SystemStryker GmbH20250
K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250
K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240

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 24 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
  • 16 of the 66 ancestors have a recall of any class.
  • Of its descendants, K241563 (Extremity Medical, LLC, 2025) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K090926.

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?

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. Pseudarthrosis 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…

Read the full statement (213 words)

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. Pseudarthrosis 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

1. Open and closed fractures fixation

2. Bony or soft tissue deformities

3. Infected fractures

4. Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius

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. Pseudarthrosis of long bones

4. Limb lengthening by distraction

5. Correction of bony or soft tissue deformities

6. Infected fractures

7. Nonunions

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. Pseudarthrosis of long bones

4. Limb lengthening by distraction

5. Correction of bony or soft tissue deformities

6. Joint arthrodesis

7. Infected fractures

8. Nonunions

Indications for use as stated in the FDA summary.

Also cleared against K090926

2 other devices cite the same predicate.

  • K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd. · 2020
  • K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012

More from Smith & Nephew

16 FDA decisions under this applicant name. See the company

  • K241666EVOS Pelvic and Acetabular SystemSmith & Nephew · 2025
  • K240487EVOS Patella PlatesSmith & Nephew · 2024
  • K233730Footprint Mini PK, 3.5mm Suture AnchorSmith & Nephew · 2024
  • K232457Q-FIX ULTRA All-Suture AnchorSmith & Nephew · 2023
  • K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023

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/K201253 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201253: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201253

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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