# K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 29, 2018 after 182 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933785 (1995). 41 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872379: Insall/Burstein* II Modular Total Knee, Zimmer, Inc. (1987) Summary page 25.
- K892800: MG II Porous Total Knee System, Zimmer, Inc. (1989) Summary page 25.
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 25.
- K946150: Cruciate Retaining (Augmentable) and Constrained Condylar Knee (CCK), Zimmer, Inc. (1995) Summary page 25.
- K951185: Nexgen Complete Knee Solution 9MM Articular Surface, Zimmer, Inc. (1996) Summary page 25.
- K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces, Zimmer, Inc. (1996) Summary page 26.
- K963148: Nexgen Complete Knee Solution, Zimmer, Inc. (1997) Summary page 26.
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999) Summary page 26.
- K003910: Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining (CR) Articular Surface Components, Zimmer, Inc. (2001) Summary page 26.
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components, Zimmer, Inc. (2002) Summary page 26.
- K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components, Zimmer, Inc. (2003) Summary page 26.
- K041100: Nexgen Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate Components, Zimmer, Inc. (2004) Summary page 26.
- K043101: Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions, Zimmer, Inc. (2005) Summary page 26.
- K042271: Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular Surfaces, Zimmer, Inc. (2004) Summary page 26.
- K052879: Nexgen Complete Knee Solution Mis Modular Tibial Plates and Keels, Zimmer, Inc. (2005) Summary page 26.
- K060370: Nexgen Knee Gender Solutions Female (GSF) Femoral Components, Zimmer, Inc. (2006) Summary page 26.
- K062768: Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and Tivanium TI-6AL-4V Alloy Femoral, Zimmer, Inc. (2006) Summary page 26.
- K072160: Nexgen Trabecular Metal Tibial Tray, Zimmer, Inc. (2007) Summary page 26.
- K072281: Nexgen Prolong All-Poly Patella, Zimmer, Inc. (2007) Summary page 26.
- K072619: Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous Femoral Components, Zimmer, Inc. (2007) Summary page 26.
- K070695: Zimmer Patellofemoral Joint Prosthesis, Zimmer, Inc. (2007) Summary page 26.
- K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee, Zimmer, Inc. (2002) Summary page 26.
- K152494: Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments, Zimmer, Inc. (2015) Summary page 26.
- K931651: Natural-Knee Congruent Tibial Insert with Screw, Intermedics Orthopedics (1994) Summary page 26.
- K935789: Posterior Stabilized Apollo Knee System, Intermedics Orthopedics (1995) Summary page 26.
- K936159: Natural-Knee II System, Intermedics Orthopedics (1995) Summary page 26.
- K970498: Natural-Knee II Revision Femoral Spacer Lugs, Intermedics Orthopedics (1997) Summary page 26.
- K972501: Apollo Revision/Constrained Knee System, Sulzer Orthopedics, Inc. (1997) Summary page 27.
- K973412: Natural-Knee II Constrained Knee System, Sulzer Orthopedics, Inc. (1997) Summary page 27.
- K982903: Sulzer Orthopedics Fluted Stems, Sulzer Orthopedics, Inc. (1998) Summary page 27.
- K983153: Natural-Knee II Posterior Stabilized (P.S.) Condylar Knee Tibial Inserts, Sulzer Orthopedics, Inc. (1998) Summary page 27.
- K002335: Natural-Knee II System-Durasul Tibial Insert and Durasul All-Poly Patella, Sulzer Orthopedics, Inc. (2000) Summary page 27.
- K013031: Most Options System, Sulzer Orthopedics, Inc. (2001) Summary page 27.
- K023528: Natural-Knee II Cemented Modular Tibial Baseplate, Centerplus Orthopedics, Inc. (2003) Summary page 27.
- K031183: Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate, Centerpulse Orthopedics, Inc. (2003) Summary page 27.
- K070214: Gender Solutions Natural-Knee Flex System, Zimmer, Inc. (2007) Summary page 27.

## Most influential descendants
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K191625: Persona Revision Knee System (2019), 1 descendant of its own
- K243724: Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (2025), 0 descendants of its own
- K210829: Persona Revision Knee System Femoral Metaphyseal Cones (2021), 0 descendants of its own
- K210551: Persona Revision Knee System (2021), 0 descendants of its own

## Recalls of this device
- May 19, 2023 · Class II · Z-2092-2023: Device outer packaging was incorrectly labeled.
- Oct 10, 2019 · Class II · Z-0321-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

## 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. CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. NexGen Augments that may be used with cemented CR, CRA, PS, LPS, and LCCK femoral and tibial baseplate components are indicated for cemented use only. 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 indicated for cemented use only. This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avasculart 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. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Plates and Keels are intended for cemented use only 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. CR-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. Specific uses with CR-Flex or LPS-Flex femorals: - Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. - The CR-Flex femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. - The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. Specific Uses with NexGen LPS or LCCK femorals: - The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees. - The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces. 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. The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only. The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation). Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: - Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. - The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. - The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. - 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. This device is intended for cemented use only. This device is indicated for patients with: - Moderate to severe knee instability. - Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle. - Valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts. This device is intended for cemented use only. The Natural-Knee System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). The Natural-Knee primary components without CSTi Porous Coating and all revision components are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary components are used, the medial and collateral ligaments must be intact. The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). The Natural-Knee II primary components without CSTi Porous Coating, all posterior stabilized and revision components, the N-K II Constrained Knee System, the modular cemented tibial baseplate, and the revision stem and revision fluted stem are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. The Natural-Knee II Durasul polyethylene components are indicated for patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. These devices are intended for cemented use only in the United States. This device is indicated for: - Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - Correctable valgus-varus deformity and moderate flexion contracture. - Those patients with failed previous surgery where pain, deformity, or dysfunction persists. - Revision of previously failed knee arthroplasty. This device is intended for cemented use only. Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen Trabecular Metal™ CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Source page: https://510kreport.com/device/K173057
Methodology: https://510kreport.com/methodology