510(k) · Cleared
ClearedAscent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral Pegs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Sep 8, 2004 as substantially equivalent to K002678 (Biomet, Inc., 2000) and 1 other predicate after a 61-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Sep 8, 2004
- Review
- 61 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K915132 (1992). 19 ancestors in all, the oldest K833921 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
- 2 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
- 1 generation backK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
- This deviceK041872 Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS)…Biomet Manufacturing Corp · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915132 | MCK Maximum Congruent Knee) Knee System | Biomet, Inc. | 1992 | 6 |
| −2 | K023546 | Maxim Accel Knee System | Biomet, Inc. | 2003 | 13 |
| −1 | K033489 | Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee… | Biomet, Inc. | 2004 | — |
| 0 (this device) | K041872 | Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal… | Biomet Manufacturing Corp | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 3 | 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 20.0 · 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? (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 |
|---|---|---|---|
| * | K002678 | Ascent Knee SystemSummary page 1…/polymer porous coated uncemented (21 CFR 888.3565) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: AscentTM Porous Open Box PS Femoral Component (K002678) and Biomet Non-Cement (K033489). Device Description: The AscentTM Porous Open Box PS Femoral Component is a metallic knee femor… | 2000 |
| * | K033489 | Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Summary page 1…d (21 CFR 888.3565) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: AscentTM Porous Open Box PS Femoral Component (K002678) and Biomet Non-Cement (K033489). Device Description: The AscentTM Porous Open Box PS Femoral Component is a metallic knee femoral component to be used with Bio… | 2004 |
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 12 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 6 of the 19 ancestors have a recall of any class.
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.
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?
Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, where one or more compartments are involved.
Correction of varus, valgus or posttraumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041872 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041872: Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral Pegs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041872
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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