510(k) · Cleared
ClearedBiomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Cleared on Feb 7, 2022 as substantially equivalent to K193546 (Biomet, Inc., 2020) after a 187-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Feb 7, 2022
- Review
- 187 days
- Class
- Class II
- Product code
- JDG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942479 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 JDG? 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 JDG device
- #1 K193546 Distal Centralizersscore 3.1 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K193546 | Distal CentralizersSummary page 4…O - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Predicate Device(s): K193546 Distal Biomet, Inc. Centralizers Device Description: The sub… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 1 company; a new generation was cleared every 26.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All JDG devicesJDG Prosthesis, Hip, Femoral Component, Cemented, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JDG
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JDG
Too few JDG 510(k)s in any year since 2007 to give a median.
Recalls per year · JDG
4in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDG
263in 2025
MAUDE reports naming product code JDG, 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 | 0 | — | 0 | 28 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 0 | — | 2 | 38 |
| 2010 | 0 | — | 0 | 37 |
| 2011 | 0 | — | 0 | 25 |
| 2012 | 0 | — | 0 | 49 |
| 2013 | 0 | — | 3 | 84 |
| 2014 | 0 | — | 0 | 145 |
| 2015 | 0 | — | 0 | 391 |
| 2016 | 0 | — | 0 | 383 |
| 2017 | 0 | — | 0 | 328 |
| 2018 | 1 | — | 0 | 447 |
| 2019 | 0 | — | 0 | 333 |
| 2020 | 1 | — | 0 | 1,046 |
| 2021 | 0 | — | 4 | 1,206 |
| 2022 | 1 | — | 0 | 886 |
| 2023 | 0 | — | 0 | 289 |
| 2024 | 0 | — | 0 | 300 |
| 2025 | 0 | — | 0 | 263 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
5. Revision of previously failed total hip arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212431: Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212431
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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