510(k) Report

510(k) · Cleared

Cleared

Tempfix External Fixation System

K021933510(k) TraditionalCleared Aug 26, 200275-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

DePuy Orthopaedics, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Aug 26, 2002 as substantially equivalent to K000957 (Howmedica Osteonics Corp., 2000) and 5 other predicates after a 75-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.

Decided
Aug 26, 2002
Review
75 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K875022 (1988). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1988: 1 other ancestor2005: 1 descendant cleared2006: 1 descendant clearedK875022 · Ace/Fisher Percutaneous Transfixing Pins · Buckman Co., Inc. · 19881990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 2 descendants K875022 · Ace/Fisher Percutaneous Transfixing Pins · Buckman Co., Inc. · 19880
  1. Root · 1 generation backK875022 Ace/Fisher Percutaneous Transfixing PinsBuckman Co., Inc. · 1988
  2. This deviceK021933 Tempfix External Fixation SystemDePuy Orthopaedics, Inc. · 2002
  3. Descendant · cites it directly · 0 of its ownK052918 Reprocessed External Fixation DevicesAlliance Medical Corp. · 2006
  4. Descendant · cites it directly · 0 of its ownK043113 Tempfix External Fixation System, MR SafeDePuy Orthopaedics, Inc. · 2005

Most influential descendants

Showing 2 of 2 · See all
  • K052918Reprocessed External Fixation DevicesAlliance Medical Corp. · 2006 · cites it directly0descendants
  • K043113Tempfix External Fixation System, MR SafeDePuy Orthopaedics, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K875022Ace/Fisher Percutaneous Transfixing PinsBuckman Co., Inc.1988—
0 (this device)K021933Tempfix External Fixation SystemDePuy Orthopaedics, Inc.2002—
+1K052918Reprocessed External Fixation DevicesAlliance Medical Corp.2006—
+1K043113Tempfix External Fixation System, MR SafeDePuy Orthopaedics, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199410
199610
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
FIG. 1 — Lineage of K021933, 1988–2006Source: 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? (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
*K000957Hoffmann II External Fixation SystemHowmedica Osteonics Corp.2000—
*K984357Transfx External Fixation System
Summary page 1
…lent Devices: Howmedica Osteonics Hoffman I1 External Fixator KO00957 Immedica Trans& External Fixation System (distributed by Zimmer) K984357 ACE Medical Company Align Fixator K936045 ACE Medical Company ACE -Fischer Pins…
Immedica, Inc.19997
*K936045Ace Unilateral Fixator II
Summary page 1
…KO00957 Immedica Trans& External Fixation System (distributed by Zimmer) K984357 ACE Medical Company Align Fixator K936045 ACE Medical Company ACE -Fischer Pins K875022…
Ace Orthopedic Manufacturing Co.1994—
*K875022Ace/Fisher Percutaneous Transfixing Pins
Summary page 1
…K984357 ACE Medical Company Align Fixator K936045 ACE Medical Company ACE -Fischer Pins K875022 K875012 ACE Medical Company ACE-DuPont Composite Rings…
Buckman Co., Inc.1988—
*K875012Ace/Fischer Percutaneous Half Pins
Summary page 1
…K936045 ACE Medical Company ACE -Fischer Pins K875022 K875012 ACE Medical Company ACE-DuPont Composite Rings K95 5388 Device Description: The TempFix External Fixa…
Buckman Co., Inc.1988—
*K955388Ace-Dupont Composite Rings
Summary page 1
…K875022 K875012 ACE Medical Company ACE-DuPont Composite Rings K95 5388 Device Description: The TempFix External Fixation System consists of components that can be assembled to provide multiple degree…
Ace Medical Co.1996—

Also cleared against K000957: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K052918Reprocessed External Fixation DevicesAlliance Medical Corp.20060
K043113Tempfix External Fixation System, MR SafeDePuy Orthopaedics, Inc.20050

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?

  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K052918 (Alliance Medical Corp., 2006) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K000957.

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—

What is it indicated for?

The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures of the distal femur, proximal tibia or distal tibia where soft tissue injury precludes the use of other fracture treatments.

The TempFix External Fixation System is intended to be non-weight bearing.

Indications for use as stated in the FDA summary.

Also cleared against K000957

1 other device cites the same predicate.

  • K022423External Fixation RingRigid FX Orthopedics, Incorporated · 2002

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, 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/K021933 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021933: Tempfix 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/K021933

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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