510(k) Report

510(k) · Cleared

Cleared

Richards External Fixation System

K870961510(k) TraditionalCleared Mar 19, 19879-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

Richards Medical Co., Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Mar 19, 1987 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 62 later devices descend from it.

Decided
Mar 19, 1987
Review
9 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
0

62 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2016: 2 descendants cleared2002: 1 descendant cleared2012: 1 descendant cleared2019: 3 descendants cleared2010: 2 descendants cleared2013: 1 descendant cleared2004: 1 descendant cleared2003: 1 descendant cleared1997: 1 descendant cleared2005: 1 descendant cleared2020: 6 descendants cleared2021: 6 descendants cleared2014: 4 descendants cleared2011: 1 descendant cleared2018: 4 descendants cleared2023: 3 descendants cleared2025: 9 descendants cleared2026: 6 descendants cleared2009: 1 descendant cleared2022: 2 descendants cleared2024: 3 descendants cleared2015: 1 descendant cleared2017: 2 descendants cleared1990200020102020
  1. This deviceK870961 Richards External Fixation SystemRichards Medical Co., Inc. · 1987
  2. Descendant · cites it directly · 51 of its ownK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
  3. Descendant · 2 generations on · 32 of its ownK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
  4. Descendant · 3 generations on · 26 of its ownK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
  5. Descendant · 4 generations on · 19 of its ownK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
  6. Descendant · 2 generations on · 18 of its ownK110069 Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

1997: 12002: 12003: 12004: 12005: 12009: 12010: 22011: 12012: 12013: 12014: 42015: 12016: 22017: 22018: 42019: 32020: 62021: 62022: 22023: 32024: 32025: 92026: 6
1997high 9 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 62 · See all
  • K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · cites it directly51descendants
  • K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014 · 2 generations on32descendants
  • K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014 · 3 generations on26descendants
  • K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015 · 4 generations on19descendants
  • K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011 · 2 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870961Richards External Fixation SystemRichards Medical Co., Inc.1987—
+1K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.20101
+2K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl2014—
+3K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl2014—
+4K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl2015—
+2K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
200310
200410
200510
200910
201020
201110
201210
201310
201440
201510
201620
201720
201840
201930
202060
202160
202220
202330
202430
202590
202660
FIG. 1 — Lineage of K870961, 1987–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (62)

See all 62

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

NumberDeviceApplicantDecidedDescendants
K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.201051
K970751Heidelberg External FixatorSmith & Nephew, Inc., Orthopaedic Div.199711
K042436Iiizarov Pulley SystemSmith & Nephew, Inc.20048
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
K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193
K012634Reprocessed External Fixation DeviceAlliance Medical, Inc.20021
K093753Mdpo Frame SystemMdpo, LLC20100
K032169Carbon Fiber Composite Circular Fixation (Cirfix) Device (Half Ring)Cyberorthology, Inc.20030

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?

  • Of its descendants, K093047 (Smith & Nephew, Inc., 2010) has gone furthest, with 51 descendants of its own.

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.

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—

More from Richards Medical Co., Inc.

71 FDA decisions under this applicant name. See the company

  • K896106Rogozinski Spinal System, Add'l ComponentsRichards Medical Co., Inc. · 1990
  • K900628Modular Hip SystemRichards Medical Co., Inc. · 1990
  • K896580Uni-Polar HeadRichards Medical Co., Inc. · 1990
  • K895241Intramedullary Hip ScrewRichards Medical Co., Inc. · 1990
  • K884824Tricon-M Total Knee SystemRichards Medical Co., Inc. · 1989

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/K870961 · printed Nov 6, 2026

Cite this page

510(k) Report. “K870961: Richards External 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/K870961

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026