510(k) · Cleared
ClearedPhysica system
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 Dec 14, 2020 as substantially equivalent to K141934 (Lima Corporate S.P.A., 2015) and 3 other predicates after a 235-day review. Its family tree reaches back 12 generations to 1981. 5 later devices descend from it.
- Decided
- Dec 14, 2020
- Review
- 235 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K810258 (1981). 133 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 2 generations backK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
- 1 generation backK193284 Physica LMC Knee SystemLima Corporate S.P.A. · 2020
- This deviceK201084 Physica systemLima Corporate S.P.A. · 2020
- Descendant · cites it directly · 2 of its ownK210554 Physica systemLima Corporate S.P.A. · 2021
- Descendant · 2 generations on · 1 of its ownK243615 Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024
- Descendant · 2 generations on · 0 of its ownK250980 Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025
- Descendant · cites it directly · 0 of its ownK213381 Physica systemLima Corporate S.P.A. · 2021 · Recalled
- Descendant · cites it directly · 0 of its ownK211938 Physica LMC Knee SystemLimacorporate · 2021
Show all 12 generations
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 6 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 5 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 4 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 3 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 2 generations backK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
- 1 generation backK193284 Physica LMC Knee SystemLima Corporate S.P.A. · 2020
- This deviceK201084 Physica systemLima Corporate S.P.A. · 2020
Most influential descendants
Showing 5 of 5 · See all- K210554Physica systemLima Corporate S.P.A. · 2021 · cites it directly2descendants
- K243615Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024 · 2 generations on1descendant
- K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025 · 2 generations on0descendants
- K213381Physica systemLima Corporate S.P.A. · 2021 · cites it directly0descendants
- K211938Physica LMC Knee SystemLimacorporate · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −11 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −10 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −9 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −8 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −7 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −6 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −5 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −4 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −3 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| −2 | K150090 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2015 | — |
| −1 | K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | 2020 | — |
| 0 (this device) | K201084 | Physica system | Lima Corporate S.P.A. | 2020 | — |
| +1 | K210554 | Physica system | Lima Corporate S.P.A. | 2021 | — |
| +2 | K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024 | — |
| +2 | K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025 | — |
| +1 | K213381 | Physica system | Lima Corporate S.P.A. | 2021 | 1 |
| +1 | K211938 | Physica LMC Knee System | Limacorporate | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K141934 | Physica KR Knee SystemSummary page 5…ices: Applicant Device name Cleared via K141934, LIMACORPORATE S.P.A PHYSICA SYSTEM K193… | 2015 |
| * | K193284 | Physica LMC Knee SystemSummary page 5…K141934, LIMACORPORATE S.P.A PHYSICA SYSTEM K193284 BIOMET MANUFACTURING CORP. VANGUARD COMPLETE KNEE SYSTEM K113550 ZIMMER, INC. NEXGEN TRABE… | 2020 |
| * | K113550 | Vanguard Complete Knee SystemSummary page 5…CA SYSTEM K193284 BIOMET MANUFACTURING CORP. VANGUARD COMPLETE KNEE SYSTEM K113550 ZIMMER, INC. NEXGEN TRABECULAR METAL TIBIAL TRAY K072160 Summary of technology comparison: The inten… | 2012 |
| * | K072160 | Nexgen Trabecular Metal Tibial TraySummary page 5…K193284 BIOMET MANUFACTURING CORP. VANGUARD COMPLETE KNEE SYSTEM K113550 ZIMMER, INC. NEXGEN TRABECULAR METAL TIBIAL TRAY K072160 Summary of technology comparison: The intended use, design, and materials of the TT Tibial Plate and the tibial liners and pate… | 2007 |
What descends from it? (5)
3 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 39 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 55 of the 133 ancestors have a recall of any class.
- Of its descendants, K210554 (Lima Corporate S.P.A., 2021) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K141934.
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?
Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: * Non-inflammatory degenerative joint disease including - osteoarthritis - traumatic arthritis, and - 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 (157 words)
Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
* Non-inflammatory degenerative joint disease including
- osteoarthritis
- traumatic arthritis, and
- 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 components are also indicated for:
* Absent or not-functioning posterior cruciate ligament;
* Severe antero-posterior instability of the knee joint.
Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of the TT Tibial Plate that is intended for uncemented use. Tibial liners can be used with cemented or uncemented tibial components.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201084: Physica system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201084
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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