510(k) · Cleared
ClearedExeter Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica, Inc. · JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis
Cleared on Feb 13, 1997 as substantially equivalent to K925883 (Osteonics Corp., 1993) and 1 other predicate after a 135-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Feb 13, 1997
- Review
- 135 days
- Class
- Class II
- Product code
- JDJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K890450 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK890450 Intermedics Apr (TM) II Femoral ComponentIntermedics Orthopedics · 1989
- This deviceK963940 Exeter MeshHowmedica, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890450 | Intermedics Apr (TM) II Femoral Component | Intermedics Orthopedics | 1989 | — |
| 0 (this device) | K963940 | Exeter Mesh | Howmedica, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 JDJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K925883 | Osteonics Microstructured Acetabular ComponentsSummary page 1…ded use, materials, design, operational principles, and indications and contraindications to Howmedica's Acetabular mesh (preamendment), and mesh marketed by Osteocnics (K925883) and Intermedics (K890450). | 1993 |
| * | K890450 | Intermedics Apr (TM) II Femoral ComponentSummary page 1…, operational principles, and indications and contraindications to Howmedica's Acetabular mesh (preamendment), and mesh marketed by Osteocnics (K925883) and Intermedics (K890450). | 1989 |
| * | — | Howmedica's Acetabular mesh (preamendment) Named without a submission number |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All JDJ devicesJDJ Mesh, Surgical, Acetabular, Hip, Prosthesis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDJ
FDA has decided no JDJ device since 2007.
Median 510(k) review, days · JDJ
Too few JDJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JDJ
No recall names JDJ since 2007.
Adverse event reports per year · JDJ
2in 2025
MAUDE reports naming product code JDJ, 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 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Exeter Mesh is intended to be used to reinforce bone when additional strengthening and support is required. The Exeter Mesh is available in four (4) styles to fit a variety of anatomical requirements. The mesh is intended to be either cemented in place or affixed with screws. Screws are provided that are 3.5mm in diameter and range in length from 10mm to 35mm.
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/K963940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963940: Exeter Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963940
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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