510(k) · Cleared
ClearedCompass Universal Hinge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc., Orthopaedic Div. · JDW Pin, Fixation, Threaded
Cleared on Apr 3, 1997 after a 35-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.
- Decided
- Apr 3, 1997
- Review
- 35 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 8 citing it directly.
- This deviceK970713 Compass Universal HingeSmith & Nephew, Inc., Orthopaedic Div. · 1997
- Descendant · cites it directly · 6 of its ownK120871 Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK980370 Biosymmetric Proximal Interphalangeal Joint FixatorBiomet, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X…Smith & Nephew · 2020
- Descendant · cites it directly · 3 of its ownK094043 LigamentotaxorArex USA · 2010
- Descendant · 2 generations on · 1 of its ownK241563 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly6descendants
- K980370Biosymmetric Proximal Interphalangeal Joint FixatorBiomet, Inc. · 1998 · cites it directly6descendants
- K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew · 2020 · cites it directly5descendants
- K094043LigamentotaxorArex USA · 2010 · cites it directly3descendants
- K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970713 | Compass Universal Hinge | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| +1 | K120871 | Smith & Nephew, Inc. External Fixation System Instrumentation | Smith & Nephew, Inc. | 2012 | — |
| +1 | K980370 | Biosymmetric Proximal Interphalangeal Joint Fixator | Biomet, Inc. | 1998 | — |
| +1 | K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator… | Smith & Nephew | 2020 | — |
| +1 | K094043 | Ligamentotaxor | Arex USA | 2010 | — |
| +2 | K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 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 |
|---|---|---|---|
| * | — | Ilizarov External Fixator Named without a submission number | |
| * | — | Dynamic Joint Distractor Named without a submission number |
What descends from it? (18)
See all 188 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120871 | Smith & Nephew, Inc. External Fixation System Instrumentation | 2012 | 6 |
| K980370 | Biosymmetric Proximal Interphalangeal Joint Fixator | 1998 | 6 |
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV… | 2020 | 5 |
| K094043 | Ligamentotaxor | 2010 | 3 |
| K132731 | Digifix External Fixation System | 2014 | 1 |
| K072432 | F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non Sterile | 2008 | 1 |
| K012634 | Reprocessed External Fixation Device | 2002 | 1 |
| K992970 | Digit Widget | 1999 | 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?
- Of its descendants, K120871 (Smith & Nephew, Inc., 2012) has gone furthest, with 6 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 | — |
What is it indicated for?
The Compass Universal Hinge is a line extension to the Ilizarov external fixation system. It is used in conjunction with the Ilizarov system to treat joint contractures and to restore mobility and function of a joint that has become stiff due to contracture or traumatic injury. The Compass Universal Hinge construct is indicated to treat post-traumatic joint contracture which has resulted in the loss of range of motion, and fractures and disease which generally may result in joint contracture or loss of range of motion.
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/K970713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970713: Compass Universal Hinge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970713
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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