510(k) · Cleared
ClearedPhysica LMC Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jan 31, 2020 as substantially equivalent to K151266 (Lima Corporate S.P.A., 2015) and 5 other predicates after a 65-day review. Its family tree reaches back 11 generations to 1981. 6 later devices descend from it.
- Decided
- Jan 31, 2020
- Review
- 65 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K810258 (1981). 132 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 2 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 1 generation backK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
- This deviceK193284 Physica LMC Knee SystemLima Corporate S.P.A. · 2020
- Descendant · cites it directly · 5 of its ownK201084 Physica systemLima Corporate S.P.A. · 2020
- Descendant · 2 generations on · 2 of its ownK210554 Physica systemLima Corporate S.P.A. · 2021
- Descendant · 3 generations on · 1 of its ownK243615 Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024
- Descendant · 3 generations on · 0 of its ownK250980 Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025
- Descendant · 2 generations on · 0 of its ownK213381 Physica systemLima Corporate S.P.A. · 2021 · Recalled
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 4 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 3 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 2 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 1 generation backK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
- This deviceK193284 Physica LMC Knee SystemLima Corporate S.P.A. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201084Physica systemLima Corporate S.P.A. · 2020 · cites it directly5descendants
- K210554Physica systemLima Corporate S.P.A. · 2021 · 2 generations on2descendants
- K243615Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024 · 3 generations on1descendant
- K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025 · 3 generations on0descendants
- K213381Physica systemLima Corporate S.P.A. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −4 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −3 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −2 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| −1 | K150090 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2015 | — |
| 0 (this device) | K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | 2020 | — |
| +1 | K201084 | Physica system | Lima Corporate S.P.A. | 2020 | — |
| +2 | K210554 | Physica system | Lima Corporate S.P.A. | 2021 | — |
| +3 | K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024 | — |
| +3 | K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025 | — |
| +2 | K213381 | Physica system | Lima Corporate S.P.A. | 2021 | 1 |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K151266 | Physica CR Knee SystemSummary page 4…Description: Physica LMC knee system is a modular knee system which consists of a Physica LMC tibial liner used in combination with the Physica CR femoral components (K151266) and the Physica tibial plate (K141934); the Physica patellar component and the Physica tibial stem, cleared in K141934, can opti… | 2015 |
| * | K141934 | Physica KR Knee SystemSummary page 4…is a modular knee system which consists of a Physica LMC tibial liner used in combination with the Physica CR femoral components (K151266) and the Physica tibial plate (K141934); the Physica patellar component and the Physica tibial stem, cleared in K141934, can optionally be used with the Physica LMC kne… | 2015 |
| * | K152008 | Physica PS Knee SystemSummary page 5…Predicate Devices: Company Device name Cleared via LIMACORPORATE Physica Knee System K151266, K141934, K152008 ZIMMER VANGUARD® K050222, K113550 ZIMMER PERSONA®… | 2015 |
| * | K050222 | Vanguard Anterior Stabilized Tibial BearingsSummary page 5…Cleared via LIMACORPORATE Physica Knee System K151266, K141934, K152008 ZIMMER VANGUARD® K050222, K113550 ZIMMER PERSONA® K150090 Summary of technology comparison: The intended use,… | 2005 |
| * | K113550 | Vanguard Complete Knee SystemSummary page 5…Cleared via LIMACORPORATE Physica Knee System K151266, K141934, K152008 ZIMMER VANGUARD® K050222, K113550 ZIMMER PERSONA® K150090 Summary of technology comparison: The intended use, design,… | 2012 |
| * | K150090 | Zimmer Persona Personalized Knee SystemSummary page 5…K151266, K141934, K152008 ZIMMER VANGUARD® K050222, K113550 ZIMMER PERSONA® K150090 Summary of technology comparison: The intended use, design, and materials of Physica LMC knee system are substantially equivale… | 2015 |
What descends from it? (6)
2 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 132 ancestors have a recall of any class.
- Of its descendants, K201084 (Lima Corporate S.P.A., 2020) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K151266.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, 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 · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
Physica total knee 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, or avascular necrosis; • Inflammatory degenerative joint disease including rheumatoid arthritis; • Correction of functional deformity; • Revision procedures where other treatments or devices have failed; and • Treatment of fractures…
Read the full statement (112 words)
Physica total knee 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, or avascular necrosis;
• 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
Additional indications for Physica PS components are:
• ligamentous instability requiring implant bearing surface geometries with increased constraint (preserved and well functioning collateral ligaments are required);
• absent or not-functioning posterior cruciate ligament.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193284: Physica LMC Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193284
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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