510(k) · Cleared
ClearedPhysica CR 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 Oct 6, 2015 as substantially equivalent to K141934 (Lima Corporate S.P.A., 2015) and 2 other predicates after a 146-day review. Its family tree reaches back 8 generations to 1995. 8 later devices descend from it.
- Decided
- Oct 6, 2015
- Review
- 146 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K951987 (1995). 78 ancestors in all, the oldest K810258 (1981). 8 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 7 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 6 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- 4 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- 3 generations backK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- 2 generations backK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- 1 generation backK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
- This deviceK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
- 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
- Descendant · 2 generations on · 5 of its ownK201084 Physica systemLima Corporate S.P.A. · 2020
- Descendant · 3 generations on · 2 of its ownK210554 Physica systemLima Corporate S.P.A. · 2021
- Descendant · 4 generations on · 1 of its ownK243615 Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K152008Physica PS Knee SystemLima Corporate S.P.A. · 2015 · cites it directly7descendants
- K193284Physica LMC Knee SystemLima Corporate S.P.A. · 2020 · cites it directly6descendants
- K201084Physica systemLima Corporate S.P.A. · 2020 · 2 generations on5descendants
- K210554Physica systemLima Corporate S.P.A. · 2021 · 3 generations on2descendants
- K243615Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −7 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −6 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −5 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| −3 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| −2 | K121443 | Journey II CR Knee System | Smith & Nephew, Inc. | 2012 | — |
| −1 | K141934 | Physica KR Knee System | Lima Corporate S.P.A. | 2015 | — |
| 0 (this device) | K151266 | Physica CR Knee System | Lima Corporate S.P.A. | 2015 | — |
| +1 | K152008 | Physica PS Knee System | Lima Corporate S.P.A. | 2015 | — |
| +1 | K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | 2020 | — |
| +2 | K201084 | Physica system | Lima Corporate S.P.A. | 2020 | — |
| +3 | K210554 | Physica system | Lima Corporate S.P.A. | 2021 | — |
| +4 | K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K141934 | Physica KR Knee SystemSummary page 4…s. The tibial plates and all polyethylene patellar components are the same as the tibial plates and patellar components used for the Physica KR Knee Replacement System (K141934). Traditional 510(k) – Physica CR knee system… | 2015 |
| * | K113550 | Vanguard Complete Knee SystemSummary page 5…es. All components of the Physica CR knee system are intended for cemented fixation. Predicate Devices Physica KR (Limacorporate, K141934); Vanguard (Biomet, K113550); Scorpio (Stryker, K974556). Basis of Substantial Equivalency The Physica CR knee system components share the same materi… | 2012 |
| * | K974556 | Osteonics Scorpio Posterior Cruciate Retaining Total Knee SystemSummary page 5…a CR knee system are intended for cemented fixation. Predicate Devices Physica KR (Limacorporate, K141934); Vanguard (Biomet, K113550); Scorpio (Stryker, K974556). Basis of Substantial Equivalency The Physica CR knee system components share the same materials, intended use and basic desig… | 1998 |
What descends from it? (8)
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 20 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 33 of the 78 ancestors have a recall of any class.
- Of its descendants, K152008 (Lima Corporate S.P.A., 2015) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K141934.
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 CR 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.
Physica CR knee system is intended for cemented fixation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151266: Physica CR 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/K151266
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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