510(k) · Cleared
ClearedTriathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on May 13, 2020 as substantially equivalent to K051380 (Howmedica Osteonics Corp., 2005) and 2 other predicates after a 48-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- May 13, 2020
- Review
- 48 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K943462 (1994). 84 ancestors in all, the oldest K880155 (1988). No later device cites it as a predicate yet.
- Root · 10 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 6 generations between
- 3 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- 2 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- 1 generation backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- This deviceK200782 Triathlon Posterior Stabilized Femoral Component - beaded with…Howmedica Osteonics Corp. · 2020
Show all 10 generations
- Root · 10 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 9 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 8 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 7 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 6 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 5 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 4 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 3 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- 2 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- 1 generation backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- This deviceK200782 Triathlon Posterior Stabilized Femoral Component - beaded with…Howmedica Osteonics Corp. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −9 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −8 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −7 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −6 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −5 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −4 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| −3 | K133039 | Restoris Multicompartmental Knee System | Mako Surgical Corporation | 2013 | — |
| −2 | K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015 | — |
| −1 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
| 0 (this device) | K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite… | Howmedica Osteonics Corp. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 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? (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 |
|---|---|---|---|
| * | K051380 | Triathlon Press-Fit Total Knee SystemSummary page 6…is Claimed: Triathlon® Posterior Stabilized Femoral Component - beaded with Peri-Apatite and Triathlon® Cruciate Retaining Femoral Component - beaded with Peri-Apatite - K051380, K141056 and K172326. Device Description: The Triathlon® Posterior Stabilized (PS) Femoral Component - beaded with Peri-Apatite… | 2005 |
| * | K141056 | Triathlon Knee System Posterior Stabilized ComponentsSummary page 6…d: Triathlon® Posterior Stabilized Femoral Component - beaded with Peri-Apatite and Triathlon® Cruciate Retaining Femoral Component - beaded with Peri-Apatite - K051380, K141056 and K172326. Device Description: The Triathlon® Posterior Stabilized (PS) Femoral Component - beaded with Peri-Apatite (PA) and… | 2014 |
| * | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemSummary page 6…® Posterior Stabilized Femoral Component - beaded with Peri-Apatite and Triathlon® Cruciate Retaining Femoral Component - beaded with Peri-Apatite - K051380, K141056 and K172326. Device Description: The Triathlon® Posterior Stabilized (PS) Femoral Component - beaded with Peri-Apatite (PA) and Triathlon®… | 2017 |
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 26 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 46 of the 84 ancestors have a recall of any class.
- 7 other devices also cite its predicate K051380.
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. 2020, 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?
General Total Knee Arthroplasty (TKR) Indications: • Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. • Post-traumatic loss of knee joint configuration and function. • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate…
Read the full statement (273 words)
General Total Knee Arthroplasty (TKR) Indications:
• Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
• Post-traumatic loss of knee joint configuration and function.
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• Revision of previous unsuccessful knee replacement or other procedure.
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques.
The Triathlon Tritanium Tibial Baseplate and Tritanium Metal-Backed Patella components are indicated for both uncemented and cemented use.
The Triathlon Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon All Polyethylene tibial components are indicated for cemented use only.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
• Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• Absent or non-functioning posterior cruciate ligament.
• Severe anteroposterior instability of the knee joint.
Additional Indications for Total Stabilizer (TS) Components:
• Severe instability of the knee secondary to compromised collateral ligament integrity or function.
Indications for Bone Augments:
• Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
• Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied bone loss.
Additional Indications for Cone Augments
• Severe degeneration or trauma requiring extensive resection and replacement
• Femoral and tibial bone voids
• Metaphyseal reconstruction
The Triathlon Tritanium® Cone Augment components are intended for cemented or cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200782 · printed Nov 5, 2026
Cite this page
510(k) Report. “K200782: Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K200782
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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