510(k) Report

510(k) · Cleared

Cleared

Smith & Nephew, Inc. External Fixation System Instrumentation

K120871510(k) TraditionalCleared Jun 7, 201277-day reviewClass II21 CFR 888.3040

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

Smith & Nephew, Inc. · JDW Pin, Fixation, Threaded

Cleared on Jun 7, 2012 as substantially equivalent to K870961 (Richards Medical Co., Inc., 1987) and 16 other predicates after a 77-day review. Its family tree reaches back 10 generations to 1996. 6 later devices descend from it.

Decided
Jun 7, 2012
Review
77 days
Class
Class II
Product code
JDW
Recalls
None
Predicates
18

Its longest line of descent runs back 10 generations to K962616 (1996). 64 ancestors in all, the oldest K792022 (1979). 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 1 other ancestor2004: 6 other ancestors2003: 3 other ancestors2002: 2 other ancestors2000: 7 other ancestors1997: 3 other ancestors1996: 4 other ancestors1995: 2 other ancestors1992: 1 other ancestor1987: 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 ancestor2020: 1 descendant cleared2025: 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 16 other ancestors2 generations back: 1 other ancestor3 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: 1 descendant2 generations forward: 5 descendants K093047 · 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 · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 6 generations between
  3. 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  4. 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  5. 1 generation backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
  6. This deviceK120871 Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
  7. Descendant · cites it directly · 5 of its ownK201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X…Smith & Nephew · 2020
  8. Descendant · 2 generations on · 1 of its ownK241563 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
  9. Descendant · 2 generations on · 0 of its ownK253291 Excelsior SystemBlue Ocean Global · 2026
  10. Descendant · 2 generations on · 0 of its ownK253202 Hoffmann LRF SystemStryker GmbH · 2025
  11. Descendant · 2 generations on · 0 of its ownK251128 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
Show all 10 generations
  1. Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 1 generation backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
  11. This deviceK120871 Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2020: 12024: 12025: 32026: 1
2020high 3 (2025) · low 0 (2021)2026

Most influential descendants

Showing 5 of 6 · See all
  • K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew · 2020 · cites it directly5descendants
  • K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 2 generations on1descendant
  • K253291Excelsior SystemBlue Ocean Global · 2026 · 2 generations on0descendants
  • K253202Hoffmann LRF SystemStryker GmbH · 2025 · 2 generations on0descendants
  • K251128Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202410
202530
202610
FIG. 1 — Lineage of K120871, 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 JDW? 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 JDW device

  1. #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 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? (18)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K870961Richards External Fixation System
Summary page 1
…- Smooth or threaded metallic bone fixation fastener Device Class: Class 11 Panel Code: Orthopaedics/87 Predicate Devices: Richards External Fixation System (K(870961); Richards Titanium Half Pin (K(920024); Hex-Field Fixator (K(953397); llizarov External Fixation System…
Richards Medical Co., Inc.1987—
*K920024Rihards Titanium Half Pin
Summary page 1
…tener Device Class: Class 11 Panel Code: Orthopaedics/87 Predicate Devices: Richards External Fixation System (K(870961); Richards Titanium Half Pin (K(920024); Hex-Field Fixator (K(953397); llizarov External Fixation System (K962808); Compass Universal Hinge (K(9…
Smith & Nephew Richards, Inc.1992—
*K953397Hex-Fix Field Fixator
Summary page 1
…ode: Orthopaedics/87 Predicate Devices: Richards External Fixation System (K(870961); Richards Titanium Half Pin (K(920024); Hex-Field Fixator (K(953397); llizarov External Fixation System (K962808); Compass Universal Hinge (K(970713); Heidelberg External Fi…
Smith & Nephew Richards, Inc.1995—
*K962808Ilizarov External Fixation System
Summary page 1
…ards External Fixation System (K(870961); Richards Titanium Half Pin (K(920024); Hex-Field Fixator (K(953397); llizarov External Fixation System (K962808); Compass Universal Hinge (K(970713); Heidelberg External Fixator (K(970751) Taylor Spatial Frame Externa…
Smith & Nephew Richards, Inc.1996—
*K970713Compass Universal Hinge
Summary page 1
…Richards Titanium Half Pin (K(920024); Hex-Field Fixator (K(953397); llizarov External Fixation System (K962808); Compass Universal Hinge (K(970713); Heidelberg External Fixator (K(970751) Taylor Spatial Frame External Fixation System (K(970748); S&N Ex…
Smith & Nephew, Inc., Orthopaedic Div.1997—
*K970751Heidelberg External Fixator
Summary page 1
…Hex-Field Fixator (K(953397); llizarov External Fixation System (K962808); Compass Universal Hinge (K(970713); Heidelberg External Fixator (K(970751) Taylor Spatial Frame External Fixation System (K(970748); S&N External Fixation System (K(994143); jet-X…
Smith & Nephew, Inc., Orthopaedic Div.1997—
*K970748Taylor Spatial Frame External Fixation System
Summary page 1
…ion System (K962808); Compass Universal Hinge (K(970713); Heidelberg External Fixator (K(970751) Taylor Spatial Frame External Fixation System (K(970748); S&N External Fixation System (K(994143); jet-X TiN Coated Half Pins (K(023134); Jet-X HA Coated Half Pi…
Smith & Nephew, Inc., Orthopaedic Div.1997—
*K994143Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…
Summary page 1
…inge (K(970713); Heidelberg External Fixator (K(970751) Taylor Spatial Frame External Fixation System (K(970748); S&N External Fixation System (K(994143); jet-X TiN Coated Half Pins (K(023134); Jet-X HA Coated Half Pins (K(023921); External Fixation Systems…
Smith & Nephew, Inc.200019
*K023134Jet-X Tin Coated Half Pins
Summary page 1
…xator (K(970751) Taylor Spatial Frame External Fixation System (K(970748); S&N External Fixation System (K(994143); jet-X TiN Coated Half Pins (K(023134); Jet-X HA Coated Half Pins (K(023921); External Fixation Systems (1(031181); Modification to Jet-X HA Co…
Smith & Nephew, Inc.2002—
*K023921Jet-X HA Coated Half Pins
Summary page 1
…External Fixation System (K(970748); S&N External Fixation System (K(994143); jet-X TiN Coated Half Pins (K(023134); Jet-X HA Coated Half Pins (K(023921); External Fixation Systems (1(031181); Modification to Jet-X HA Coated Half Pins (K(033289); Jet-X Bar C…
Smith & Nephew, Inc.200327
*K031181External Fixation Systems
Summary page 1
…&N External Fixation System (K(994143); jet-X TiN Coated Half Pins (K(023134); Jet-X HA Coated Half Pins (K(023921); External Fixation Systems (1(031181); Modification to Jet-X HA Coated Half Pins (K(033289); Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe (K(0…
Smith & Nephew, Inc.2003—
*K033289Modification to Jet-X HA Coated Half Pins
Summary page 1
…ed Half Pins (K(023134); Jet-X HA Coated Half Pins (K(023921); External Fixation Systems (1(031181); Modification to Jet-X HA Coated Half Pins (K(033289); Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe (K(04231 2); Ilizarov Pulley System (K(042436); J…
Smith & Nephew, Inc.2004—
*K042312Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR SafeSmith & Nephew, Inc.2004—
*K042436Iiizarov Pulley System
Summary page 1
…Modification to Jet-X HA Coated Half Pins (K(033289); Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe (K(04231 2); Ilizarov Pulley System (K(042436); Jet-X Bar System Clamps, Bars, and Posts- MR Safe (K(072212); Smith and Nephew Rail System (K(090926);…
Smith & Nephew, Inc.2004—
*K072212Jet-X Bar System Clamps, Bars and Posts-MR Safe
Summary page 1
…et-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe (K(04231 2); Ilizarov Pulley System (K(042436); Jet-X Bar System Clamps, Bars, and Posts- MR Safe (K(072212); Smith and Nephew Rail System (K(090926); Smith and Nephew Circular Fixation System (K(093047); Smith a…
Smith & Nephew, Inc.2008—
*K090926Smith & Nephew Rail System
Summary page 1
…fe (K(04231 2); Ilizarov Pulley System (K(042436); Jet-X Bar System Clamps, Bars, and Posts- MR Safe (K(072212); Smith and Nephew Rail System (K(090926); Smith and Nephew Circular Fixation System (K(093047); Smith and Nephew Spatialframe V4.1 Web-Based Software (1…
Smith & Nephew, Inc.2009—
*K093047Smith & Nephew Circular Fixation System
Summary page 1
…Jet-X Bar System Clamps, Bars, and Posts- MR Safe (K(072212); Smith and Nephew Rail System (K(090926); Smith and Nephew Circular Fixation System (K(093047); Smith and Nephew Spatialframe V4.1 Web-Based Software (1(10069) Device Description Subject of this Traditional 510…
Smith & Nephew, Inc.20101
Kept off the family treeK100069Smith and Nephew Spatialframe V4.1 Web-Based Software
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

Also cleared against K870961: 9 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205

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 16 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
  • 16 of the 64 ancestors have a recall of any class.
  • Of its descendants, K201253 (Smith & Nephew, 2020) has gone furthest, with 5 descendants of its own.
  • 9 other devices also cite its predicate K870961.

How does its category compare?

All JDW devices

JDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · JDW

2in 2025

2007: 22009: 12010: 22011: 12012: 12013: 22014: 22015: 12017: 12018: 12019: 12020: 22021: 22022: 22025: 22026 (partial year): 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDW

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

Recalls per year · JDW

21in 2018

2009: 22010: 22012: 522017: 22018: 21
2007high 52 (2012) · low 0 (2007)2026

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

Adverse event reports per year · JDW

29in 2025

2007: 252008: 262009: 292010: 292011: 552012: 752013: 692014: 272015: 702016: 462017: 432018: 942019: 5752020: 4022021: 1682022: 1212023: 722024: 652025: 29
2007high 575 (2019) · low 25 (2007)2025

MAUDE reports naming product code JDW, 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—025
20080—026
20091—229
20102—229
20111—055
20121—5275
20132—069
20142—027
20151—070
20160—046
20171—243
20181—2194
20191—0575
20202—0402
20212—0168
20222—0121
20230—072
20240—065
20252—029
20261—0—

What is it indicated for?

The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in: 1. Post-Traumatic joint contracture which has resulted in loss of range of motion (not applicable for Smith & Nephew Rail System) 2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 3. Open and closed fracture fixation 4. Pseudoarthrosis of long bones 5. Limb lengthening by epiphyseal or…

Read the full statement (192 words)

The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in:

1. Post-Traumatic joint contracture which has resulted in loss of range of motion (not applicable for Smith & Nephew Rail System)

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

3. Open and closed fracture fixation

4. Pseudoarthrosis of long bones

5. Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X Fixator)

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

7. Correction of segmental bony or soft tissue defects

8. Joint arthrodesis (not applicable for Smith & Nephew Rail System)

9. Infected fractures or nonunions

10. Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius (not applicable for Smith & Nephew Rail System)

11. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints. As well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (not applicable for Smith & Nephew Rail System)

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
  • K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 20101 recall
  • 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 JDW

The JDW category page

  • K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc. · 2026
  • K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC · 2025
  • K241357XT3 SystemBiodynamik, Inc. · 2025
  • K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. · 2022
  • K213874MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022

https://510kreport.com/device/K120871 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120871: Smith & Nephew, Inc. External Fixation System Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120871

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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