510(k) Report

510(k) · Cleared

Cleared

Heidelberg External Fixator

K970751510(k) TraditionalCleared Apr 16, 199744-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., Orthopaedic Div. · JDW Pin, Fixation, Threaded

Cleared on Apr 16, 1997 as substantially equivalent to K953397 (Smith & Nephew Richards, Inc., 1995) and 2 other predicates after a 44-day review. Its family tree reaches back 1 generation to 1980. 11 later devices descend from it.

Decided
Apr 16, 1997
Review
44 days
Class
Class II
Product code
JDW
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K802814 (1980). 3 ancestors in all. 11 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1987: 1 other ancestor2009: 1 descendant cleared2012: 1 descendant cleared2020: 2 descendants cleared2025: 4 descendants cleared2026: 2 descendants cleared2024: 1 descendant clearedK802814 · Orthofix Axialexternal Fixation Sys. · Cintor Orthopaedic Div. · 198019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K802814 · Orthofix Axialexternal Fixation Sys. · Cintor Orthopaedic Div. · 19800
  1. Root · 1 generation backK802814 Orthofix Axialexternal Fixation Sys.Cintor Orthopaedic Div. · 1980
  2. This deviceK970751 Heidelberg External FixatorSmith & Nephew, Inc., Orthopaedic Div. · 1997
  3. Descendant · cites it directly · 10 of its ownK090926 Smith & Nephew Rail SystemSmith & Nephew, Inc. · 2009
  4. Descendant · cites it directly · 6 of its ownK120871 Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
  5. Descendant · cites it directly · 5 of its ownK201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X…Smith & Nephew · 2020
  6. Descendant · 2 generations on · 2 of its ownK200518 Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd. · 2020
  7. Descendant · 2 generations on · 1 of its ownK241563 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2009: 12012: 12020: 22024: 12025: 42026: 2
2009high 4 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 11 · See all
  • K090926Smith & Nephew Rail SystemSmith & Nephew, Inc. · 2009 · cites it directly10descendants
  • K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly6descendants
  • K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew · 2020 · cites it directly5descendants
  • K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd. · 2020 · 2 generations on2descendants
  • K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K802814Orthofix Axialexternal Fixation Sys.Cintor Orthopaedic Div.1980—
0 (this device)K970751Heidelberg External FixatorSmith & Nephew, Inc., Orthopaedic Div.1997—
+1K090926Smith & Nephew Rail SystemSmith & Nephew, Inc.2009—
+1K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.2012—
+1K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator…Smith & Nephew2020—
+2K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd.2020—
+2K241563Extremity Medical External Fixation SystemExtremity Medical, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
202020
202410
202540
202620
FIG. 1 — Lineage of K970751, 1980–2026Source: 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? (3)

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
*K953397Hex-Fix Field Fixator
Summary page 1
…ernal Fixator APR ) 6 1997 Substantial Equivalence Information The Heidelberg External Fixator is substantially equivalent to the following: 1. Hex-Fix Field Fixator--K953397 2. Orthofix External Fixator--K802814 3. Ilizarov External Fixator System--K870961 All of the devices listed above have similar…
Smith & Nephew Richards, Inc.1995—
*K802814Orthofix Axialexternal Fixation Sys.
Summary page 1
…al Equivalence Information The Heidelberg External Fixator is substantially equivalent to the following: 1. Hex-Fix Field Fixator--K953397 2. Orthofix External Fixator--K802814 3. Ilizarov External Fixator System--K870961 All of the devices listed above have similar indications for use, similar materials…
Cintor Orthopaedic Div.1980—
*K870961Richards External Fixation System
Summary page 1
…ternal Fixator is substantially equivalent to the following: 1. Hex-Fix Field Fixator--K953397 2. Orthofix External Fixator--K802814 3. Ilizarov External Fixator System--K870961 All of the devices listed above have similar indications for use, similar materials composition, and similar design. The safety…
Richards Medical Co., Inc.1987—

Also cleared against K953397: 4 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K090926Smith & Nephew Rail SystemSmith & Nephew, Inc.200910
K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126
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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K090926 (Smith & Nephew, Inc., 2009) has gone furthest, with 10 descendants of its own.
  • 4 other devices also cite its predicate K953397.

How does its category compare?

All JDW devices

JDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Indications for the Heidelberg Fixator include: fracture fixation (open and closed), pseudoarthrosis or nonunion of long bones; limb lengthening, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K953397

4 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
  • K090926Smith & Nephew Rail SystemSmith & Nephew, Inc. · 2009
  • K023134Jet-X Tin Coated Half PinsSmith & Nephew, Inc. · 2002

More from Smith & Nephew, Inc., Orthopaedic Div.

10 FDA decisions under this applicant name. See the company

  • K991538Opera Cupflanged Acetabular ComponentsSmith & Nephew, Inc., Orthopaedic Div. · 1999
  • K970635Titanium Spinal Rod SystemSmith & Nephew, Inc., Orthopaedic Div. · 1997
  • K971414Zirconia Prozyr Ceramic 12/14 Global Taper (GT) Femoral HeadsSmith & Nephew, Inc., Orthopaedic Div. · 1997
  • K970748Taylor Spatial Frame External Fixation SystemSmith & Nephew, Inc., Orthopaedic Div. · 1997
  • K970713Compass Universal HingeSmith & Nephew, Inc., Orthopaedic Div. · 1997

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/K970751 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970751: Heidelberg External Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970751

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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