510(k) · Cleared
ClearedExternal Fixation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanta Orthopaedics, Inc. · JDW Pin, Fixation, Threaded
Cleared on Jul 17, 1998 as substantially equivalent to K974911 (Avanta Orthopaedics, Inc., 1998) and 1 other predicate after a 63-day review. Its family tree reaches back 2 generations to 1983. 2 later devices descend from it.
- Decided
- Jul 17, 1998
- Review
- 63 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K831576 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 1 generation backK974911 External FixatorAvanta Orthopaedics, Inc. · 1998
- This deviceK981716 External FixationAvanta Orthopaedics, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK101375 Trimed X-FixTriMed, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK122208 External Fixator SystemChristopher D. Endara · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −1 | K974911 | External Fixator | Avanta Orthopaedics, Inc. | 1998 | — |
| 0 (this device) | K981716 | External Fixation | Avanta Orthopaedics, Inc. | 1998 | — |
| +1 | K101375 | Trimed X-Fix | TriMed, Inc. | 2010 | — |
| +2 | K122208 | External Fixator System | Christopher D. Endara | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 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 JDW? 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 JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K974911 | External FixatorSummary page 1…ce: Device Description: External Fixator External Fixator Class I Orthopaedic 888.3040 ‘Smooth or threaded metallic bone fixation fastener. JWD Avanta Orthopaedics (K974911) EBI/Orthofix K831576 The external fixator like the predicate device includes various size frames, bars, pin clamps, pins, acc… | 1998 |
| * | K831576 | OrthofixSummary page 1…: External Fixator External Fixator Class I Orthopaedic 888.3040 ‘Smooth or threaded metallic bone fixation fastener. JWD Avanta Orthopaedics (K974911) EBI/Orthofix K831576 The external fixator like the predicate device includes various size frames, bars, pin clamps, pins, accessories and instrument… | 1983 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101375 | Trimed X-Fix | 2010 | 1 |
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 14.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101375 (TriMed, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K974911.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, 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 | 2 | — | 0 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The intended use of the external fixation device is the same as that expressed in the predicate device 510k.
The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis. fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
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/K981716 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981716: External Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981716
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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