510(k) · Cleared
ClearedApex Fixation Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · JDW Pin, Fixation, Threaded
Cleared on May 4, 2001 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- May 4, 2001
- Review
- 21 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK011136 Apex Fixation PinsHowmedica Osteonics Corp. · 2001
- Descendant · cites it directly · 2 of its ownK110965 Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011
- Descendant · cites it directly · 2 of its ownK080408 External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100…Advanced Orthopaedic Solutions, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK141912 Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone…Advanced Orthopaedic Solutions, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK232897 Arthrex Small External Fixation SystemArthrex, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK213905 ONX Large External Fixation SystemOrthonovis, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K110965Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011 · cites it directly2descendants
- K080408External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External Fixaton Clamp…Advanced Orthopaedic Solutions, Inc. · 2008 · cites it directly2descendants
- K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc. · 2014 · 2 generations on1descendant
- K232897Arthrex Small External Fixation SystemArthrex, Inc. · 2023 · 3 generations on0descendants
- K213905ONX Large External Fixation SystemOrthonovis, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011136 | Apex Fixation Pins | Howmedica Osteonics Corp. | 2001 | — |
| +1 | K110965 | Renovis T 710 Large External Fixation System | Renovis Surgical Technologies, LLC | 2011 | — |
| +1 | K080408 | External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External… | Advanced Orthopaedic Solutions, Inc. | 2008 | — |
| +2 | K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External… | Advanced Orthopaedic Solutions, Inc. | 2014 | — |
| +3 | K232897 | Arthrex Small External Fixation System | Arthrex, Inc. | 2023 | — |
| +2 | K213905 | ONX Large External Fixation System | Orthonovis, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
4 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?
- Of its descendants, K110965 (Renovis Surgical Technologies, LLC, 2011) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K011136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011136: Apex Fixation Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011136
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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