510(k) · Cleared
Recalled · Class II · 2019Colles C Series Frame Sterile Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jan 29, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 29, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK003397 Colles C Series Frame Sterile PackDePuy Orthopaedics, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK012294 Wristore FixatorMillennium Medical Technologies, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK042761 Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK101338 Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V · 2011
- Descendant · 3 generations on · 0 of its ownK052498 Fragment Specific FixatorDavid J. Slutsky MD · 2005
- Descendant · cites it directly · 0 of its ownK013503 Modification to: Sterile Colles Classic FixatorDePuy Orthopaedics, Inc. · 2001 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K012294Wristore FixatorMillennium Medical Technologies, Inc. · 2002 · cites it directly3descendants
- K042761Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004 · 2 generations on1descendant
- K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V · 2011 · 2 generations on0descendants
- K052498Fragment Specific FixatorDavid J. Slutsky MD · 2005 · 3 generations on0descendants
- K013503Modification to: Sterile Colles Classic FixatorDePuy Orthopaedics, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003397 | Colles C Series Frame Sterile Pack | DePuy Orthopaedics, Inc. | 2001 | — |
| +1 | K012294 | Wristore Fixator | Millennium Medical Technologies, Inc. | 2002 | — |
| +2 | K042761 | Wristore Distal Radius Fracture Fixator, 4600 Series | Zimmer, Inc. | 2004 | — |
| +2 | K101338 | Newfix External Fixation System | Technologia Y Diseno Industrial, S.A DE C.V | 2011 | — |
| +3 | K052498 | Fragment Specific Fixator | David J. Slutsky MD | 2005 | — |
| +1 | K013503 | Modification to: Sterile Colles Classic Fixator | DePuy Orthopaedics, Inc. | 2001 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
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 K242861 TrueLok Elevatescore 21.4 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K012294 (Millennium Medical Technologies, Inc., 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KTT devicesKTT 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
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 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 | — |
https://510kreport.com/device/K003397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003397: Colles C Series Frame Sterile Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003397
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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