510(k) · Cleared
ClearedPhysica KR 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 Apr 2, 2015 as substantially equivalent to K033260 (Aap Implantate AG, 2004) and 3 other predicates after a 259-day review. Its family tree reaches back 7 generations to 1995. 18 later devices descend from it.
- Decided
- Apr 2, 2015
- Review
- 259 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K951987 (1995). 42 ancestors in all, the oldest K915132 (1992). 18 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 6 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 5 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- 3 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- 2 generations backK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- 1 generation backK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- This deviceK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
- Descendant · cites it directly · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
- Descendant · cites it directly · 8 of its ownK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
- Descendant · 2 generations on · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
- Descendant · cites it directly · 7 of its ownK152008 Physica PS Knee SystemLima Corporate S.P.A. · 2015
- Descendant · cites it directly · 6 of its ownK193284 Physica LMC Knee SystemLima Corporate S.P.A. · 2020
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · cites it directly8descendants
- K151266Physica CR Knee SystemLima Corporate S.P.A. · 2015 · cites it directly8descendants
- K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · 2 generations on7descendants
- K152008Physica PS Knee SystemLima Corporate S.P.A. · 2015 · cites it directly7descendants
- K193284Physica LMC Knee SystemLima Corporate S.P.A. · 2020 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −6 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −5 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −4 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| −3 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| −2 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| −1 | K121443 | Journey II CR Knee System | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K141934 | Physica KR Knee System | Lima Corporate S.P.A. | 2015 | — |
| +1 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019 | — |
| +1 | K151266 | Physica CR Knee System | Lima Corporate S.P.A. | 2015 | — |
| +2 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | — |
| +1 | K152008 | Physica PS Knee System | Lima Corporate S.P.A. | 2015 | — |
| +1 | K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K033260 | AequosSummary page 5…nt of fractures that are unmanageable using other techniques. Physica knee system is intended for cemented fixation. Predicate Devices x G1 knee system (Aequos, K033260); x Journey II CR knee system (Smith&Nephew, K121443) and Genesis II (Smith&Nephew, K951987); x EVOLUTION MP tot… | 2004 |
| * | K121443 | Journey II CR Knee SystemSummary page 5…es. Physica knee system is intended for cemented fixation. Predicate Devices x G1 knee system (Aequos, K033260); x Journey II CR knee system (Smith&Nephew, K121443) and Genesis II (Smith&Nephew, K951987); x EVOLUTION MP total knee system (Wright Medical Technology, K093552). Basi… | 2012 |
| * | K951987 | Genesis II Total Knee SystemSummary page 5…ted fixation. Predicate Devices x G1 knee system (Aequos, K033260); x Journey II CR knee system (Smith&Nephew, K121443) and Genesis II (Smith&Nephew, K951987); x EVOLUTION MP total knee system (Wright Medical Technology, K093552). Basis of Substantial Equivalency The subject Phys… | 1995 |
| * | K093552 | Evolution MP Total Knee SystemSummary page 5…x Journey II CR knee system (Smith&Nephew, K121443) and Genesis II (Smith&Nephew, K951987); x EVOLUTION MP total knee system (Wright Medical Technology, K093552). Basis of Substantial Equivalency The subject Physica KR knee system and all of the predicates are semi-constrained, fixed bea… | 2010 |
What descends from it? (18)
See all 185 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 20 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 22 of the 42 ancestors have a recall of any class.
- Of its descendants, K190911 (Limacorporate, 2019) has gone furthest, with 8 descendants of its own.
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. 2015, 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:
x Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
x Inflammatory degenerative joint disease including rheumatoid arthritis;
x Correction of functional deformity;
x Revision procedures where other treatments or devices have failed; and
x Treatment of fractures that are unmanageable using other techniques.
Physica knee system is intended for cemented fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141934: Physica KR 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/K141934
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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