510(k) · Cleared
ClearedDuracon Extra-Small Stabilizer Tibial Insert & Baseplate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 22, 1997 as substantially equivalent to K932070 (Howmedica Corp., 1995) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- May 22, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915512 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915512 Duracon Total Knee System Tibial ComponentsPfizer Hospital Products Group, Inc. · 1992 · Recalled
- This deviceK970758 Duracon Extra-Small Stabilizer Tibial Insert & BaseplateHowmedica Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915512 | Duracon Total Knee System Tibial Components | Pfizer Hospital Products Group, Inc. | 1992 | 4 |
| 0 (this device) | K970758 | Duracon Extra-Small Stabilizer Tibial Insert & Baseplate | Howmedica Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 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 |
|---|---|---|---|
| * | K932070 | Duracon Stabilizer Femoral Component and InsertSummary page 1…e individuals. These components are substantially equivalent to other legally marketed devices. These devices include: 1) Duracon® Stabilizer Tibial Insert (Howmedica - K932070) ‘and 2) Duracon® Universal Baseplate (Howmedica - K915512). This substantial equivalence is based on similarities in intended… | 1995 |
| * | K915512 | Duracon Total Knee System Tibial ComponentsSummary page 1…t to other legally marketed devices. These devices include: 1) Duracon® Stabilizer Tibial Insert (Howmedica - K932070) ‘and 2) Duracon® Universal Baseplate (Howmedica - K915512). This substantial equivalence is based on similarities in intended use, design, materials, and surgical placement. Testing of… | 1992 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 4 other devices also cite its predicate K932070.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The Duracon® Extra-Small Stabilizer Tibial insert and Baseplate are intended to be used with previously released Duracon femoral and patellar components as a total knee system in primary or revision cemented total knee arthroplasty. These components are specificaily intended to be used in situations where the posterior cruciate ligament.is not intact, not present, or cannot be repaired. The collateral ligaments should be intact, or repaired so that adequate mediolateral stability is present. These components are intended to be implanted using bone cement in small boned, skeletally mature individuals.
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/K970758 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970758: Duracon Extra-Small Stabilizer Tibial Insert & Baseplate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970758
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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