510(k) · Cleared
ClearedBiosymmetric Proximal Interphalangeal Joint Fixator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Apr 14, 1998 as substantially equivalent to K970713 (Smith & Nephew, Inc., Orthopaedic Div., 1997) after a 74-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.
- Decided
- Apr 14, 1998
- Review
- 74 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970713 (1997). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK970713 Compass Universal HingeSmith & Nephew, Inc., Orthopaedic Div. · 1997
- This deviceK980370 Biosymmetric Proximal Interphalangeal Joint FixatorBiomet, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK094043 LigamentotaxorArex USA · 2010
- Descendant · cites it directly · 1 of its ownK132731 Digifix External Fixation SystemVirak Orthopedic Research, LLC · 2014
- Descendant · cites it directly · 1 of its ownK992970 Digit WidgetHand Biomechanics Lab, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK192465 DigiFix Sterile KitVirak Orthopedics, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK122415 X-Fix Dynamic External DistractorArex USA, LLC · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K094043LigamentotaxorArex USA · 2010 · cites it directly3descendants
- K132731Digifix External Fixation SystemVirak Orthopedic Research, LLC · 2014 · cites it directly1descendant
- K992970Digit WidgetHand Biomechanics Lab, Inc. · 1999 · cites it directly1descendant
- K192465DigiFix Sterile KitVirak Orthopedics, LLC · 2019 · 2 generations on0descendants
- K122415X-Fix Dynamic External DistractorArex USA, LLC · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970713 | Compass Universal Hinge | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| 0 (this device) | K980370 | Biosymmetric Proximal Interphalangeal Joint Fixator | Biomet, Inc. | 1998 | — |
| +1 | K094043 | Ligamentotaxor | Arex USA | 2010 | — |
| +1 | K132731 | Digifix External Fixation System | Virak Orthopedic Research, LLC | 2014 | — |
| +1 | K992970 | Digit Widget | Hand Biomechanics Lab, Inc. | 1999 | — |
| +2 | K192465 | DigiFix Sterile Kit | Virak Orthopedics, LLC | 2019 | — |
| +2 | K122415 | X-Fix Dynamic External Distractor | Arex USA, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.4 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K970713 | Compass Universal HingeSummary page 1…tivity Disassociation of the components Substantial Equivalent Device: Compass® Proximal Interphalangeal (PIP) Hinge from Smith & Nephew Richards cleared through 510(k) K970713. MATLING ADDRESS SHIPPING ADDRESS PO Box 587 Airport Industrial Puaok Warsaaw, IN 465581 0587 Wirsaw, IN 46580 OUrICE N FAX | i-… | 1997 |
What descends from it? (6)
3 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?
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
1) Complex fracture-dislocations of the proximal Interphalangeal joint.
2) Unstable PIP dislocations
3) Post-traumatic contracture of the PIP joint
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/K980370 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980370: Biosymmetric Proximal Interphalangeal Joint Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980370
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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