510(k) · Cleared
Recalled · Class II · 2017Persona Partial Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Nov 3, 2016 as substantially equivalent to K010685 (Zimmer, Inc., 2001) and 6 other predicates after a 147-day review. Its family tree reaches back 10 generations to 1981. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 3, 2016
- Review
- 147 days
- Class
- Class II
- Product code
- HSX
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 10 generations to K810258 (1981). 55 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations between
- 3 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 2 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 1 generation backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
- This deviceK161592 Persona Partial Knee SystemBiomet, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK212870 TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK261609 Freedom Partial Knee SystemMaxx Orthopedics, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251771 Cambridge Partial KneeSignature Orthopaedics Pty, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK251834 Persona Partial KneeZimmer Biomet · 2025
- Descendant · cites it directly · 0 of its ownK200151 Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right…Zimmer, Inc. · 2020
Show all 10 generations
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 4 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 3 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 2 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 1 generation backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
- This deviceK161592 Persona Partial Knee SystemBiomet, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd. · 2022 · cites it directly2descendants
- K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc. · 2026 · 2 generations on0descendants
- K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd. · 2025 · 2 generations on0descendants
- K251834Persona Partial KneeZimmer Biomet · 2025 · cites it directly0descendants
- K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −9 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −8 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −7 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −6 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −5 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −4 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −3 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −2 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −1 | K122529 | Zimmer Unicompartmental Knee System Vivacit-E Articular Surface | Zimmer, Inc. | 2012 | — |
| 0 (this device) | K161592 | Persona Partial Knee System | Biomet, Inc. | 2016 | — |
| +1 | K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | 2022 | — |
| +2 | K261609 | Freedom Partial Knee System | Maxx Orthopedics, Inc. | 2026 | — |
| +2 | K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | 2025 | — |
| +1 | K251834 | Persona Partial Knee | Zimmer Biomet | 2025 | — |
| +1 | K200151 | Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona… | Zimmer, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K010685 | Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular…Summary page 5…metal/polymer (21 CFR §888.3520) Legally marketed devices to which substantial equivalence is claimed: • Miller/Galante Unicompartmental Knee (K010685/K942263/K880155) • Zimmer Unicompartmental Knee System (K122529/K033363) • Repicci II Unicondylar Knee (K971938) • Alleg… | 2001 |
| * | K942263 | Miller/Galante Precoat Unicompartmental Knee SystemSummary page 5…metal/polymer (21 CFR §888.3520) Legally marketed devices to which substantial equivalence is claimed: • Miller/Galante Unicompartmental Knee (K010685/K942263/K880155) • Zimmer Unicompartmental Knee System (K122529/K033363) • Repicci II Unicondylar Knee (K971938) • Allegretto Un… | 1995 |
| * | K880155 | Miller/Galante Precoat Unicompartmental KneeSummary page 5…metal/polymer (21 CFR §888.3520) Legally marketed devices to which substantial equivalence is claimed: • Miller/Galante Unicompartmental Knee (K010685/K942263/K880155) • Zimmer Unicompartmental Knee System (K122529/K033363) • Repicci II Unicondylar Knee (K971938) • Allegretto Unicompart… | 1988 |
| * | K122529 | Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceSummary page 5…rketed devices to which substantial equivalence is claimed: • Miller/Galante Unicompartmental Knee (K010685/K942263/K880155) • Zimmer Unicompartmental Knee System (K122529/K033363) • Repicci II Unicondylar Knee (K971938) • Allegretto Unicompartmental Knee (K011954) • Zimmer Persona Personali… | 2012 |
| * | K033363 | Zimmer Unicompartmental Knee SystemSummary page 5…evices to which substantial equivalence is claimed: • Miller/Galante Unicompartmental Knee (K010685/K942263/K880155) • Zimmer Unicompartmental Knee System (K122529/K033363) • Repicci II Unicondylar Knee (K971938) • Allegretto Unicompartmental Knee (K011954) • Zimmer Persona Personalized Knee… | 2004 |
| * | K971938 | Repicci II Unicondylar KneeSummary page 5…claimed: • Miller/Galante Unicompartmental Knee (K010685/K942263/K880155) • Zimmer Unicompartmental Knee System (K122529/K033363) • Repicci II Unicondylar Knee (K971938) • Allegretto Unicompartmental Knee (K011954) • Zimmer Persona Personalized Knee System (K113369/K121771/K150090) – referen… | 1997 |
| * | K011954 | Sulzer Orthopedics Allegretto Unicompartmental KneeSummary page 5…ee (K010685/K942263/K880155) • Zimmer Unicompartmental Knee System (K122529/K033363) • Repicci II Unicondylar Knee (K971938) • Allegretto Unicompartmental Knee (K011954) • Zimmer Persona Personalized Knee System (K113369/K121771/K150090) – reference device for A/P medial dimensions, MR… | 2001 |
| † | K113369 | Zimmer Persona Knee System | 2012 |
| † | K121771 | Zimmer Persona the Personalized Knee System | 2012 |
| † | K150090 | Zimmer Persona Personalized Knee System | 2015 |
| † | K141407 | Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial | 2014 |
| † | K122160 | Vanguard XP Knee System | 2013 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2017 | Class II | Z-1238-2018 | Nonconforming Material/Component | Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle. |
| Jul 5, 2017 | Class II | Z-0349-2018 | Device Design | Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 19 of the 55 ancestors have a recall of any class.
- Of its descendants, K212870 (Signature Orthopaedics Pty, Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K010685.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications: - Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis; - traumatic arthritis; - previous tibial condyle or plateau fractures with loss of anatomy or function; - varus deformities; and - revision of the articular surface of a…
Read the full statement (213 words)
The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:
- Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;
- traumatic arthritis;
- previous tibial condyle or plateau fractures with loss of anatomy or function;
- varus deformities; and
- revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.
The Persona Partial Knee System is a single use implant intended for implantation with bone cement.
Indications for combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ):
- Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
- The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).
- History of patellar dislocation or patella fracture.
- Dysplasia-induced degeneration.
These indications will be used for the combined medial unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions.
Combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ) implants are intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161592: Persona Partial 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/K161592
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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