510(k) · Cleared

Recalled · Class II · 2019

Modification to: Sterile Colles Classic Fixator

K013503510(k) SpecialCleared Nov 16, 200125-day reviewClass II21 CFR 888.3030Recalls 1

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 Nov 16, 2001 as substantially equivalent to K003397 (DePuy Orthopaedics, Inc., 2001) after a 25-day review. Its family tree reaches back 1 generation to 2001. It has been recalled once.

Decided: Nov 16, 2001
Review: 25 days
Class: Class II
Product code: KTT
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K003397 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK003397 Colles C Series Frame Sterile PackDePuy Orthopaedics, Inc. · 2001 · Recalled
This deviceK013503 Modification to: Sterile Colles Classic FixatorDePuy Orthopaedics, Inc. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003397	Colles C Series Frame Sterile Pack	DePuy Orthopaedics, Inc.	2001	1
0 (this device)	K013503	Modification to: Sterile Colles Classic Fixator	DePuy Orthopaedics, Inc.	2001	—

FIG. 1 — Lineage of K013503, 2001–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K003397	Colles C Series Frame Sterile Pack Summary page 1 …e component. No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems. Sterile Colles Fixator K003397 The Colles C Series Frame Sterile Pack is an external fixation device used in the treatment of fractures of the wrist. The syste…	DePuy Orthopaedics, Inc.	2001	1

Also cleared against K003397: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 21, 2019	Class II	Z-0528-2020	Environmental control	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
1 other device also cites its predicate K003397.

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

2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	9	55	2	45
2008	11	73	1	66
2009	11	94	2	45
2010	12	148	1	121
2011	10	157	0	196
2012	9	140	4	527
2013	7	87	7	898
2014	14	129	0	445
2015	12	60	0	401
2016	10	142	0	400
2017	11	184	1	485
2018	6	149	14	597
2019	8	110	3	800
2020	9	200	0	942
2021	10	83	2	961
2022	3	25	0	627
2023	7	29	0	554
2024	5	90	0	523
2025	10	88	0	673
2026	5	68	11	—

What is it indicated for?

For use in the fixation of distal fractures of the upper extremity. External fixation systems allow control of bone segments including angulation, rotation and displacement.

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

https://510kreport.com/device/K013503 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013503: Modification to: Sterile Colles Classic Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013503

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026