510(k) · Cleared
ClearedDigit Widget
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hand Biomechanics Lab, Inc. · JDW Pin, Fixation, Threaded
Cleared on Nov 8, 1999 as substantially equivalent to K980370 (Biomet, Inc., 1998) and 1 other predicate after a 66-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Nov 8, 1999
- Review
- 66 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970713 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK970713 Compass Universal HingeSmith & Nephew, Inc., Orthopaedic Div. · 1997
- 1 generation backK980370 Biosymmetric Proximal Interphalangeal Joint FixatorBiomet, Inc. · 1998
- This deviceK992970 Digit WidgetHand Biomechanics Lab, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK020311 Clearview Wrist FixatorRigid FX Orthopedics, Incorporated · 2002
Most influential descendants
Showing 1 of 1 · See all- K020311Clearview Wrist FixatorRigid FX Orthopedics, Incorporated · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970713 | Compass Universal Hinge | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| −1 | K980370 | Biosymmetric Proximal Interphalangeal Joint Fixator | Biomet, Inc. | 1998 | — |
| 0 (this device) | K992970 | Digit Widget | Hand Biomechanics Lab, Inc. | 1999 | — |
| +1 | K020311 | Clearview Wrist Fixator | Rigid FX Orthopedics, Incorporated | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K980370 | Biosymmetric Proximal Interphalangeal Joint FixatorSummary page 1…ontractures with an associated loss of range of motion ) Predicate Devices: The Proximal Interphalangeal (PIP) Joint External Fixation devices marketed by BIOMET, Inc. (K980370) and Smith Nephew Richards (K970713) represent predicate devices relative to the Hand Biomechanics Lab, Inc. Digit Widget . Clin… | 1998 |
| * | K970713 | Compass Universal HingeSummary page 1…of range of motion ) Predicate Devices: The Proximal Interphalangeal (PIP) Joint External Fixation devices marketed by BIOMET, Inc. (K980370) and Smith Nephew Richards (K970713) represent predicate devices relative to the Hand Biomechanics Lab, Inc. Digit Widget . Clinical Tests: None Adverse S&E Inform… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020311 | Clearview Wrist Fixator | 2002 | 0 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K020311 (Rigid FX Orthopedics, Incorporated, 2002) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K980370.
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 Hand Biomechanics Lab, Inc. Digit Widget is intended for the following indication:
1. PIP joint flexion contractures with an associated 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/K992970 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992970: Digit Widget.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992970
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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