# K113369: Zimmer Persona Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 27, 2012 after 133 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933785 (1995). 14 ancestors in all.
96 later devices descend from it; 17 cite it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936159: Natural-Knee II System, Intermedics Orthopedics (1995) Summary page 1.
- K070214: Gender Solutions Natural-Knee Flex System, Zimmer, Inc. (2007) Summary page 1.
- K073286: Gender Solutions Natural-Knee Flex System, Zimmer, Inc. (2008) Summary page 1.
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 1.
- K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces, Zimmer, Inc. (1996) Summary page 1.
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999) Summary page 1.
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components, Zimmer, Inc. (2002) Summary page 2.
- K060370: Nexgen Knee Gender Solutions Female (GSF) Femoral Components, Zimmer, Inc. (2006) Summary page 2.

## Most influential descendants
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K140833: Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 26 descendants of its own
- K122765: Persona Natural Tibia Baseplates (2012), 25 descendants of its own
- K142404: iTotal Posterior Stabilized (PS) Knee Replacement System (2014), 24 descendants of its own
- K142161: Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 24 descendants of its own

## Recalls of this device
- Aug 7, 2017 · Class II · Z-1806-2018: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surf
- Aug 7, 2017 · Class II · Z-1808-2018: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surf
- Aug 7, 2017 · Class II · Z-1805-2018: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surf
- Aug 7, 2017 · Class II · Z-1807-2018: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surf
- Mar 17, 2016 · Class II · Z-1340-2016: The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 a
- Mar 17, 2016 · Class II · Z-1341-2016: The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 a
- Jan 11, 2016 · Class II · Z-1157-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Mar 10, 2015 · Class II · Z-1360-2015: Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to p
- Dec 4, 2014 · Class II · Z-0853-2015: The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Persona Cemente
- Nov 25, 2014 · Class II · Z-1042-2015: Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increas
- Oct 9, 2014 · Class II · Z-0198-2015: Cleaning process validation failure.
- Oct 7, 2014 · Class II · Z-0123-2015: Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
- Aug 7, 2014 · Class II · Z-2575-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Aug 7, 2014 · Class II · Z-2577-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Aug 7, 2014 · Class II · Z-2580-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Aug 7, 2014 · Class II · Z-2579-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Aug 7, 2014 · Class II · Z-2578-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Aug 7, 2014 · Class II · Z-2576-2014: Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all d
- Jun 10, 2013 · Class II · Z-2296-2014: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken ea
- Jun 10, 2013 · Class II · Z-2297-2014: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken ea
- Jun 10, 2013 · Class II · Z-2299-2014: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken ea
- Nov 14, 2012 · Class II · Z-0539-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0543-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0544-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0546-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0547-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0550-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0553-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0554-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0540-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0545-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0548-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0552-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0541-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0542-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0549-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0551-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Nov 14, 2012 · Class II · Z-0555-2013: All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and r
- Sep 7, 2012 · Class II · Z-2493-2012: Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perforation durin

## Indications for use
This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K113369
Methodology: https://510kreport.com/methodology