510(k) · Cleared
ClearedRegenerex Porous Titanium Sleeve Augments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 5, 2007 as substantially equivalent to K053505 (Biomet Manufacturing, Inc., 2006) and 1 other predicate after a 77-day review. Its family tree reaches back 4 generations to 1998. 4 later devices descend from it.
- Decided
- Nov 5, 2007
- Review
- 77 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K982302 (1998). 13 ancestors in all, the oldest K915132 (1992). 4 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 3 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 2 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 1 generation backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
- This deviceK072336 Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp · 2007
- Descendant · cites it directly · 0 of its ownK233507 EVOLUTION® Tibial ConesMicroport Orthopedics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK170149 3DMetal Tibial ConesMedacta International S.A. · 2017
- Descendant · cites it directly · 0 of its ownK140883 Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK100370 Symmetric Total Knee AgumentsSignal Medical Corp. · 2011
Most influential descendants
Showing 4 of 4 · See all- K233507EVOLUTION® Tibial ConesMicroport Orthopedics, Inc. · 2024 · cites it directly0descendants
- K1701493DMetal Tibial ConesMedacta International S.A. · 2017 · cites it directly0descendants
- K140883Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc. · 2014 · cites it directly0descendants
- K100370Symmetric Total Knee AgumentsSignal Medical Corp. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −3 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −2 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −1 | K053340 | Trabecular Metal Tibial and Femoral Cone Augments | Zimmer Trabecular | 2006 | — |
| 0 (this device) | K072336 | Regenerex Porous Titanium Sleeve Augments | Biomet Manufacturing Corp | 2007 | — |
| +1 | K233507 | EVOLUTION® Tibial Cones | Microport Orthopedics, Inc. | 2024 | — |
| +1 | K170149 | 3DMetal Tibial Cones | Medacta International S.A. | 2017 | — |
| +1 | K140883 | Vanguard 360 Osseoti Tibial Sleeve Augment | Biomet, Inc. | 2014 | — |
| +1 | K100370 | Symmetric Total Knee Aguments | Signal Medical Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K053505 | Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsSummary page 1…tal/polymer constrained cemented prosthesis (888.3510) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Regenerex'T m Knee Augments (Biomet, Inc.)- K053505 and Trabiecular Metal' Tm Tibial and Femoral Cone Augments (Zimmer, Inc.)- K053340 Device Description: The RegenereX'TM Porous T… | 2006 |
| * | K053340 | Trabecular Metal Tibial and Femoral Cone AugmentsSummary page 1…Which Substantial Equivalence Is Claimed: Regenerex'T m Knee Augments (Biomet, Inc.)- K053505 and Trabiecular Metal' Tm Tibial and Femoral Cone Augments (Zimmer, Inc.)- K053340 Device Description: The RegenereX'TM Porous Titanium Sleeve Augments are truncated cones with a centrally located bore that are… | 2006 |
What descends from it? (4)
4 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 13 ancestors have a recall of any class.
- Of its descendants, K233507 (Microport Orthopedics, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K053505.
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. 2007, this device’s year, is highlighted.
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 Regenerex TM Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the following cemented systems: the Vanguard TM , Ascent Tm, and Maxim® knee systems, as well as the Biomet® Tibial Augmentation Components, Stemmed Tibial Components, Offset Tibial Trays and Offset Tibial Tray Adaptors. The Regenerex TM Porous Titanium Sleeve Augments are indicated for use with following uncemented system: the Vanguard TM…
Read the full statement (206 words)
The Regenerex TM Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the following cemented systems: the Vanguard TM , Ascent Tm, and Maxim® knee systems, as well as the Biomet® Tibial Augmentation Components, Stemmed Tibial Components, Offset Tibial Trays and Offset Tibial Tray Adaptors. The Regenerex TM Porous Titanium Sleeve Augments are indicated for use with following uncemented system: the Vanguard TM Non-Cemented Porous Coated Knee Components.
Specific indications are as follows:
1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
These are single use implants.
Cemented and uncemented applications.
The RegenereX'TM Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the OSS™ system.
Specific indications are as follows:
1. Painful and disabled knee joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
2. Correction of varus, valgus, or posttraumnatic deformity.
3. Correction or revision of unsuccessful osteotomny, arthrodesis, or previous joint replacement.
4. Ligament deficiencies.
5. Tumor resection.
6. Trauma.
These are single use implants.
Cemented applications only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072336 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072336: Regenerex Porous Titanium Sleeve Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072336
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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