510(k) · Cleared
Recalled · Class II · 2020Regenerex Tibial Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Apr 21, 2008 as substantially equivalent to K053505 (Biomet Manufacturing, Inc., 2006) and 4 other predicates after a 70-day review. Its family tree reaches back 4 generations to 1998. 13 later devices descend from it. It has been recalled once.
- Decided
- Apr 21, 2008
- Review
- 70 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 4 generations to K982302 (1998). 24 ancestors in all, the oldest K833921 (1984). 13 later devices descend from it, 2 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 backK053505 Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc. · 2006
- This deviceK080361 Regenerex Tibial ComponentsBiomet, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK101994 Apex Knee Modular Tibia SystemOmnlife Science · 2010 · Recalled
- Descendant · cites it directly · 5 of its ownK171054 Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK131472 Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 4 of its ownK153437 Apex Revision Knee SystemOmnilife Science · 2015 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K101994Apex Knee Modular Tibia SystemOmnlife Science · 2010 · cites it directly6descendants
- K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · cites it directly5descendants
- K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013 · 2 generations on5descendants
- K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · 2 generations on4descendants
- K153437Apex Revision Knee SystemOmnilife Science · 2015 · 3 generations on4descendants
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 | K053505 | Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments | Biomet Manufacturing, Inc. | 2006 | — |
| 0 (this device) | K080361 | Regenerex Tibial Components | Biomet, Inc. | 2008 | — |
| +1 | K101994 | Apex Knee Modular Tibia System | Omnlife Science | 2010 | 1 |
| +1 | K171054 | Biomet Knee Joint Replacement Prostheses | Biomet, Inc. | 2017 | 4 |
| +2 | K131472 | Apex Knee Modular Tibia System | Omni Life Science, Inc. | 2013 | — |
| +2 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
| +3 | K153437 | Apex Revision Knee System | Omnilife Science | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 3 | 0 |
| 2025 | 2 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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…MBH, )WH Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Regenerex TM Ultra Porous Construct-Femoral and Tibial K053505 Biomet Manufacturing Corp. Knee Augments Biomet's Non-Cemented Porous Knee Components K033489… | 2006 |
| * | K033489 | Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Summary page 1…uct-Femoral and Tibial K053505 Biomet Manufacturing Corp. Knee Augments Biomet's Non-Cemented Porous Knee Components K033489 Biomet Manufacturing Corp. Trabecular Metal Tibial and Patellar Components for the K031462 Zimmer/Implex… | 2004 |
| * | K031462 | The Nexgen Knee System Uncemented ComponentsSummary page 1…ented Porous Knee Components K033489 Biomet Manufacturing Corp. Trabecular Metal Tibial and Patellar Components for the K031462 Zimmer/Implex Corporation NexGen® Knee System AGC® Revision Knee Prosthesis K03… | 2003 |
| * | K912245 | Agc Revision Knee ProthesisSummary page 1…C® Revision Knee Prosthesis K033489 Biomet, Inc. K912245 Kirschner Performance Total Knee System Porous Coated K874547 Kirschner Medical Corporation Device Descr… | 1991 |
| * | K874547 | Kirschner Perform Total Knee System Porous CoatedSummary page 1…iomet, Inc. K912245 Kirschner Performance Total Knee System Porous Coated K874547 Kirschner Medical Corporation Device Description: The RegenerexTM Tibial Components are intended for primary knee arthroplast… | 1987 |
What descends from it? (13)
See all 132 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2020 | Class II | Z-0081-2021 | Process change control | Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 24 ancestors have a recall of any class.
- Of its descendants, K101994 (Omnlife Science, 2010) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K053505.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
The indications for the RegenerexTM Tibial Components include:
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 devices are single-use implants intended for cemented or uncemented
applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080361: Regenerex Tibial Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080361
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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