510(k) · Cleared
Recalled · 2005Hoffmann II Compact External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · JEC Component, Traction, Invasive
Cleared on Jul 17, 1997 after a 66-day review. The FDA summary names its predicate without a number. 10 later devices descend from it. It has been recalled once.
- Decided
- Jul 17, 1997
- Review
- 66 days
- Class
- Class II
- Product code
- JEC
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 6 citing it directly.
- This deviceK971755 Hoffmann II Compact External Fixation SystemHowmedica Corp. · 1997
- Descendant · cites it directly · 2 of its ownK012648 Reprocessed Howmedica External Fixation DevicesAlliance Medical Corp. · 2002
- Descendant · cites it directly · 1 of its ownK141912 Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone…Advanced Orthopaedic Solutions, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK071628 Stryker External Fixation SystemStryker Cmf · 2007
- Descendant · 2 generations on · 1 of its ownK052062 Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK232897 Arthrex Small External Fixation SystemArthrex, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K012648Reprocessed Howmedica External Fixation DevicesAlliance Medical Corp. · 2002 · cites it directly2descendants
- K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc. · 2014 · cites it directly1descendant
- K071628Stryker External Fixation SystemStryker Cmf · 2007 · cites it directly1descendant
- K052062Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp. · 2005 · 2 generations on1descendant
- K232897Arthrex Small External Fixation SystemArthrex, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971755 | Hoffmann II Compact External Fixation System | Howmedica Corp. | 1997 | — |
| +1 | K012648 | Reprocessed Howmedica External Fixation Devices | Alliance Medical Corp. | 2002 | — |
| +1 | K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External… | Advanced Orthopaedic Solutions, Inc. | 2014 | — |
| +1 | K071628 | Stryker External Fixation System | Stryker Cmf | 2007 | — |
| +2 | K052062 | Alliance Medical Corporation Reprocessed External Fixation Devices | Alliance Medical Corp. | 2005 | — |
| +2 | K232897 | Arthrex Small External Fixation System | Arthrex, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 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 JEC? 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 JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | — | Original Hoffmann® External Fixation System Named without a submission number | |
| * | — | Hoffmann® II External Fixation System Named without a submission number |
What descends from it? (10)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012648 | Reprocessed Howmedica External Fixation Devices | 2002 | 2 |
| K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation… | 2014 | 1 |
| K071628 | Stryker External Fixation System | 2007 | 1 |
| K122208 | External Fixator System | 2012 | 0 |
| K101338 | Newfix External Fixation System | 2011 | 0 |
| K042066 | Klsa Martin Hand Distractor | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 17, 2005 | Not classified | Z-2080-2008 | Device Design | Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012648 (Alliance Medical Corp., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hoffmann® II Compact External Fixation System is intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting. And other means of internal fixation.
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/K971755 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971755: Hoffmann II Compact External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971755
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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