510(k) · Cleared
ClearedPhysica PS 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 29, 2015 as substantially equivalent to K141934 (Lima Corporate S.P.A., 2015) and 4 other predicates after a 100-day review. Its family tree reaches back 9 generations to 1995. 7 later devices descend from it.
- Decided
- Oct 29, 2015
- Review
- 100 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K951987 (1995). 81 ancestors in all, the oldest K810258 (1981). 7 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 5 generations between
- 3 generations backK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- 2 generations backK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
- 1 generation backK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
- This deviceK152008 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
- Descendant · 4 generations on · 0 of its ownK250980 Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025
Show all 9 generations
- Root · 9 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 8 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 7 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- 5 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- 4 generations backK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- 3 generations backK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- 2 generations backK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
- 1 generation backK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
- This deviceK152008 Physica PS Knee SystemLima Corporate S.P.A. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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
- K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −8 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −7 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −6 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| −4 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| −3 | K121443 | Journey II CR Knee System | Smith & Nephew, Inc. | 2012 | — |
| −2 | K141934 | Physica KR Knee System | Lima Corporate S.P.A. | 2015 | — |
| −1 | K151266 | Physica CR Knee System | Lima Corporate S.P.A. | 2015 | — |
| 0 (this device) | 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 | — |
| +4 | 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 |
|---|---|---|
| 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 | 3 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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…combination with a Physica tibial plate, a Physica patellar component and, if required, a Physica tibial stem that were cleared as part of the Physica KR knee system in K141934. The Physica PS knee system components are intended to be used with bone cement. The femoral components are made of CoCrMo allo… | 2015 |
| * | K151266 | Physica CR Knee System Cleared while this submission was under review Summary page 5…ibial plates, all polyethylene patellar components and the tibial stems are the same devices as used for the Physica KR Knee System (K141934) and Physica CR Knee System (K151266). Intended Use Physica knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following co… | 2015 |
| * | K121879 | Vega Knee SystemSummary page 5…sterior instability of the knee joint. Predicate Devices Physica KR (Limacorporate, K141934); Physica CR (Limacorporate, K151266); Vega System (Aesculap, K121879); Journey BCS (Smith & Nephew, K042515); Vanguard PS (Biomet, K113550). Basis of Substantial Equivalency The Physica P… | 2012 |
| * | K042515 | Smith & Nephew, Inc. High Performance KneeSummary page 5…icate Devices Physica KR (Limacorporate, K141934); Physica CR (Limacorporate, K151266); Vega System (Aesculap, K121879); Journey BCS (Smith & Nephew, K042515); Vanguard PS (Biomet, K113550). Basis of Substantial Equivalency The Physica PS knee system components share the same mate… | 2005 |
| * | K113550 | Vanguard Complete Knee SystemSummary page 5…orporate, K141934); Physica CR (Limacorporate, K151266); Vega System (Aesculap, K121879); Journey BCS (Smith & Nephew, K042515); Vanguard PS (Biomet, K113550). Basis of Substantial Equivalency The Physica PS knee system components share the same materials, intended use and basic design… | 2012 |
What descends from it? (7)
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 20 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 33 of the 81 ancestors have a recall of any class.
- Of its descendants, K193284 (Lima Corporate S.P.A., 2020) has gone furthest, with 6 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 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…
Read the full statement (102 words)
Physica 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.
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.
Physica 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/K152008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152008: Physica PS 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/K152008
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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