510(k) · Cleared
ClearedReprocessed External Fixation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical, Inc. · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Cleared on Jun 24, 2002 as substantially equivalent to K870961 (Richards Medical Co., Inc., 1987) and 2 other predicates after a 315-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Jun 24, 2002
- Review
- 315 days
- Class
- Class II
- Product code
- KTW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K870961 (1987). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK870961 Richards External Fixation SystemRichards Medical Co., Inc. · 1987
- This deviceK012634 Reprocessed External Fixation DeviceAlliance Medical, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK051554 Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp. · 2005
Most influential descendants
Showing 1 of 1 · See all- K051554Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870961 | Richards External Fixation System | Richards Medical Co., Inc. | 1987 | — |
| 0 (this device) | K012634 | Reprocessed External Fixation Device | Alliance Medical, Inc. | 2002 | — |
| +1 | K051554 | Alliance Medical Corporation Reprocessed External Fixation Devices | Alliance Medical Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 KTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K870961 | Richards External Fixation SystemSummary page 3…TH & NEPHEW RICHARDS, INC. 20-1700 CONICALWASHER COUPLE SMITH & NEPHEW RICHARDS, INC. 7101-2005 NYLON INSERT NUT Predicate device(s): K870961 Smith & Nephew Richards, Inc., External Fixation System… | 1987 |
| * | K962808 | Ilizarov External Fixation SystemSummary page 3…K870961 Smith & Nephew Richards, Inc., External Fixation System K962808 Smith & Nephew Richards, Ilizarov External Fixation System… | 1996 |
| * | K970713 | Compass Universal HingeSummary page 3…K962808 Smith & Nephew Richards, Ilizarov External Fixation System K970713 Smith & Nephew Richards Compass@ Proximal Interphalangeal (PIP) Hinge Device des… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051554 | Alliance Medical Corporation Reprocessed External Fixation Devices | 2005 | 0 |
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?
How does its category compare?
All KTW devicesKTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KTW
Too few KTW 510(k)s in any year since 2007 to give a median.
Recalls per year · KTW
57in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTW
96in 2025
MAUDE reports naming product code KTW, 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 | 0 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 57 | 26 |
| 2011 | 0 | — | 0 | 21 |
| 2012 | 1 | — | 0 | 70 |
| 2013 | 0 | — | 0 | 70 |
| 2014 | 0 | — | 0 | 62 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 2 | — | 0 | 27 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 1 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 60 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 0 | — | 0 | 123 |
| 2025 | 0 | — | 0 | 96 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Reprocessed external fixation devices are indicated for use in
patients requiring external skeletal fixation and treatment of fractures, osteotomy,
arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures,
limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft
tissue defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012634 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012634: Reprocessed External Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012634
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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