510(k) · Cleared
ClearedAce Fischer External Fixation System
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 Mar 23, 2009 as substantially equivalent to K801594 (Ace Orthopedic Manufacturing Co., 1980) and 3 other predicates after a 94-day review. Its family tree reaches back 1 generation to 1980. 5 later devices descend from it.
- Decided
- Mar 23, 2009
- Review
- 94 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K801594 (1980). 4 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK801594 Ace Fischer External Fixation DeviceAce Orthopedic Manufacturing Co. · 1980
- This deviceK083789 Ace Fischer External Fixation SystemDePuy Orthopaedics, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK190486 Pitkar External Fixation SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK202833 Sequel External Fixation DeviceSequel Medical, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK253291 Excelsior SystemBlue Ocean Global · 2026
- Descendant · cites it directly · 0 of its ownK111993 FramewalkerQuantum Medical Concepts, LLC · 2011
- Descendant · cites it directly · 0 of its ownK093753 Mdpo Frame SystemMdpo, LLC · 2010
Most influential descendants
Showing 5 of 5 · See all- K190486Pitkar External Fixation SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2019 · cites it directly2descendants
- K202833Sequel External Fixation DeviceSequel Medical, Inc. · 2021 · 2 generations on1descendant
- K253291Excelsior SystemBlue Ocean Global · 2026 · 3 generations on0descendants
- K111993FramewalkerQuantum Medical Concepts, LLC · 2011 · cites it directly0descendants
- K093753Mdpo Frame SystemMdpo, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801594 | Ace Fischer External Fixation Device | Ace Orthopedic Manufacturing Co. | 1980 | — |
| 0 (this device) | K083789 | Ace Fischer External Fixation System | DePuy Orthopaedics, Inc. | 2009 | — |
| +1 | K190486 | Pitkar External Fixation System | S.H.Pitkar Orthotools Pvt., Ltd. | 2019 | — |
| +2 | K202833 | Sequel External Fixation Device | Sequel Medical, Inc. | 2021 | — |
| +3 | K253291 | Excelsior System | Blue Ocean Global | 2026 | — |
| +1 | K111993 | Framewalker | Quantum Medical Concepts, LLC | 2011 | — |
| +1 | K093753 | Mdpo Frame System | Mdpo, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
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 21.4 · 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? (4)
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 | Decided |
|---|---|---|---|
| * | K801594 | Ace Fischer External Fixation DeviceSummary page 1…ate The device is substantially equivalent to the currently marketed DePuy ACE- Devices Fischer External Fixation system that consists of K801 594: ACE-Fischer External Fixation System, K860014: Fischer Wire/Pin Clamp, K875012: ACE-Fischer… | 1980 |
| * | K860018 | Fischer Wire/Pin Clamp Our reading of the summary gave K860014, FDA’s number for Systems Plus (United Surgical Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Fischer Wire/Pin Clamp”. | 1986 |
| * | K875012 | Ace/Fischer Percutaneous Half PinsSummary page 1…Fischer External Fixation system that consists of K801 594: ACE-Fischer External Fixation System, K860014: Fischer Wire/Pin Clamp, K875012: ACE-Fischer Percutaneous Half Pins and K955388: ACE Dupont Composite Rings. Classification… | 1988 |
| * | K955388 | Ace-Dupont Composite RingsSummary page 1…cher External Fixation System, K860014: Fischer Wire/Pin Clamp, K875012: ACE-Fischer Percutaneous Half Pins and K955388: ACE Dupont Composite Rings. Classification Class 11,21 CFR 888.3030 and 888.3040 Performance… | 1996 |
What descends from it? (5)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K190486 (S.H.Pitkar Orthotools Pvt., Ltd., 2019) has gone furthest, with 2 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. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The updated ACE-Fischer® External Fixation System is indicated for open and closed long bone fracture fixation to include tensioned wire fixation of periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083789 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083789: Ace Fischer External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083789
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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