510(k) · Cleared
ClearedPhysica System (Physica CR Porous Femoral components)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on May 22, 2025 as substantially equivalent to K243615 (Lima Corporate S.P.A., 2024) and 2 other predicates after a 52-day review. Its family tree reaches back 15 generations to 1981.
- Decided
- May 22, 2025
- Review
- 52 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K810258 (1981). 136 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations between
- 3 generations backK201084 Physica systemLima Corporate S.P.A. · 2020
- 2 generations backK210554 Physica systemLima Corporate S.P.A. · 2021
- 1 generation backK243615 Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024
- This deviceK250980 Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025
Show all 15 generations
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 14 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 13 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 12 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 11 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 10 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 9 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 8 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 7 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 6 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 5 generations backK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
- 4 generations backK193284 Physica LMC Knee SystemLima Corporate S.P.A. · 2020
- 3 generations backK201084 Physica systemLima Corporate S.P.A. · 2020
- 2 generations backK210554 Physica systemLima Corporate S.P.A. · 2021
- 1 generation backK243615 Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024
- This deviceK250980 Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −14 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −13 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −12 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −11 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −10 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −9 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −8 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −7 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −6 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| −5 | K150090 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2015 | — |
| −4 | K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | 2020 | — |
| −3 | K201084 | Physica system | Lima Corporate S.P.A. | 2020 | — |
| −2 | K210554 | Physica system | Lima Corporate S.P.A. | 2021 | — |
| −1 | K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024 | — |
| 0 (this device) | K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 10 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K243615 | Physica Porous Femoral ComponentsSummary page 6…code via 1 (Primary Limacorporate S.p.A Physica Porous Femoral Components MBH K243615 predicate) 2 (Secondary Limacorporate S.p.A Physica system MBH, K210554 predicate)… | 2024 |
| * | K210554 | Physica systemSummary page 6…rporate S.p.A Physica Porous Femoral Components MBH K243615 predicate) 2 (Secondary Limacorporate S.p.A Physica system MBH, K210554 predicate) JWH, HRY 3 (Secondary Limacorporate S.p.A Physica… | 2021 |
| * | K151266 | Physica CR Knee SystemSummary page 5…ents) is intended for a total knee replacement. Physica CR Porous Femoral components are designed based on the cemented Physica CR Femoral components already cleared (K151266). They are made of CoCrMo (ISO 5832-4 / ASTM F75) and are intended to replace the condyles of the distal femur. The femoral com… | 2015 |
| † | K141934 | Physica KR Knee System | 2015 |
| † | K152008 | Physica PS Knee System | 2015 |
| † | K193284 | Physica LMC Knee System | 2020 |
| † | K201084 | Physica system | 2020 |
| † | K211938 | Physica LMC Knee System | 2021 |
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 44 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 55 of the 136 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. 2025, 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?
Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: • Non-inflammatory degenerative joint disease including o osteoarthritis o traumatic arthritis, and o avascular necrosis (not applicable to Physica TT Tibial Plate); • Inflammatory degenerative joint disease including rheumatoid arthritis; • Correction of functional deformity; • Revision procedures where other treatments or devices have…
Read the full statement (234 words)
Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
• Non-inflammatory degenerative joint disease including
o osteoarthritis
o traumatic arthritis, and
o avascular necrosis (not applicable to Physica TT Tibial Plate);
• Inflammatory degenerative joint disease including rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and
• Treatment of fractures that are unmanageable using other techniques.
Additional indications for Physica LMC component are:
• Moderate varus, valgus, or flexion deformities.
In patients with preserved and well functioning collateral ligaments, Physica PS, PS Pro and HPS components are also indicated for:
• Absent or not-functioning posterior cruciate ligament;
• Severe antero-posterior instability of the knee joint.
Additional indications for Physica HPS component are:
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate varus, valgus, or flexion deformities.
Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use.
Tibial liners can be used with cemented or uncemented tibial or femoral components.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250980 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250980: Physica System (Physica CR Porous Femoral components).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250980
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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