Zimmer Segmental System

K192798 · Zimmer, Inc. · KRO · Dec 10, 2020 · Orthopedic

Device Facts

• Record ID: K192798
• Device Name: Zimmer Segmental System
• Applicant: Zimmer, Inc.
• Product Code: KRO · Orthopedic
• Decision Date: Dec 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is indicated for: - Moderate to severe knee instability - Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, theumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or proximal tibia - Valgus, varus or flexion deformities - The salvage of previously failed surgical attempts · A total femoral replacement consisting of Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement. · Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented. · Fluted stem extensions require the use of either a smooth or Trabecular, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone. · The Trabecular Metal collar may be used cemented or uncemented against the bone. · All other constructs are for cemented use only.

Device Story

Zimmer Segmental System is a set of orthopedic implants for limb salvage arthroplasty; used to replace bone and joint structures in the femur and tibia. System includes segmental components, stem extensions, and collars. Operates as a passive mechanical prosthesis; implanted by orthopedic surgeons in a clinical/OR setting. Provides structural support and joint stability for patients with severe bone loss or deformity. Subject device update adds MR conditional labeling, packaging changes, and design/etching modifications. Benefits include restoration of limb function and stability in complex orthopedic cases.

Clinical Evidence

No clinical data provided. Safety and effectiveness established via non-clinical bench testing, including MRI compatibility (ASTM F2503-13, F2182-11a, F2119-07, 2052-15, F2213-17), FEA, fatigue strength, packaging (ISO 11607-1), biocompatibility (ISO 10993), and bacterial endotoxin testing (ANSI/AAMI ST 72:2011).

Technological Characteristics

Passive orthopedic implants for limb salvage. Materials identical to predicate. MR conditional per ASTM F2503-13. Testing includes RF-induced heating, image artifact, magnetic displacement, and torque. Packaging validated per ISO 11607-1. Biocompatibility per ISO 10993. Bacterial endotoxin limits ≤20 EU/Device.

Indications for Use

Indicated for patients with moderate to severe knee instability, significant bone loss/ligament deficiencies due to neoplasms, trauma, arthritis (rheumatoid, osteoarthritis, traumatic, polyarthritis), collagen disorders, or avascular necrosis of the femur/tibia, and valgus, varus, or flexion deformities. Also indicated for salvage of failed surgical attempts.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Zimmer Segmental System (K070978)
• K081860
• K101296
• K110940
• K150028
• K183136

Submission Summary (Full Text)

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December 10, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Zimmer, Inc. Yoriko Kobayashi Sr. Specialist, Regulatory Affairs 1800 W. Center Street Warsaw, Indiana 46580

Re: K192798

Trade/Device Name: Zimmer® Segmental System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO. JDI. LZO. LPH. KWY. LWJ. KWZ. KWL Dated: November 10, 2020 Received: November 12, 2020

Dear Yoriko Kobayashi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ting Song Assistant Director, Knee Arthroplasty Devices DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K192798

Device Name Zimmer Segmental System

Indications for Use (Describe)

This device is indicated for:

- Moderate to severe knee instability

- Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, theumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or proximal tibia

- Valgus, varus or flexion deformities

- The salvage of previously failed surgical attempts

· A total femoral replacement consisting of Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.

· Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.

· Fluted stem extensions require the use of either a smooth or Trabecular, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.

· The Trabecular Metal collar may be used cemented or uncemented against the bone.

· All other constructs are for cemented use only.

Type of Use (Select one or both, as applicable)

| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.3333 2.66663H2.66663C1.2 2.66663 0 3.86663 0 5.33329V13.3333C0 14.8 1.2 16 2.66663 16H13.3333C14.8 16 16 14.8 16 13.3333V5.33329C16 3.86663 14.8 2.66663 13.3333 2.66663ZM13.3333 13.3333H2.66663V5.33329H13.3333V13.3333ZM5.33329 8.00004L7.99996 10.6667L13.3333 5.33337V6.39999L8 11.7333L2.66663 6.39999V5.33337L5.33329 8.00004Z" fill="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="15" rx="1.5" stroke="black" width="15" x="0.5" y="0.5"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Zimmer Segmental System 510(k) premarket notification.

| Sponsor: | Zimmer, Inc.<br>1800 W. Center Street<br>Warsaw, IN 46580<br>Establishment Registration Number: 1822565 | Zimmer Segmental System | K070978 | |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------|---------|
| Contact Person: | Yoriko Kobayashi<br>Sr. Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] | | K081860 | |
| Date: | November 10, 2020 | | | K101296 |
| Subject Device: | Trade Name: Zimmer® Segmental System<br>Common Name: Knee Prosthesis,<br>Hip Prosthesis | | | K110940 |
| | Classification Name:<br>• KRO -Prosthesis, Knee, Femorotibial, Constrained,<br>Cemented, Metal/Polymer (21 CFR 888.3510)<br>• JDI - Prosthesis, Hip, Semi-Constrained,<br>Metal/Polymer, Cemented (21 CFR 888.3350)<br>• LZO - Prosthesis, Hip, Semi-Constrained,<br>Metal/Ceramic/Polymer, Cemented Or Non-Porous,<br>Uncemented (21 CFR 888.3353)<br>• LPH - Prosthesis, Hip, Semi-Constrained,<br>Metal/Polymer, Porous Uncemented (21 CFR<br>888.3358)<br>• KWY - Prosthesis, Hip, Hemi-, Femoral,<br>Metal/Polymer, Cemented Or Uncemented (21 CFR<br>888.3390)<br>• LWJ - Prosthesis, Hip, Semi-Constrained,<br>Metal/Polymer, Uncemented (21 CFR 888.3360)<br>• KWZ - Prosthesis, Hip, Constrained, Cemented Or<br>Uncemented, Metal/Polymer (21 CFR 888.3310)<br>• KWL - Prosthesis, Hip, Hemi-, Femoral, Metal (21<br>CFR 888.3360) | | K150028 | |
| | K183136 | | | |

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## Predicate Device(s):

#### Purpose and Device Description:

The purpose of this submission is an addition of the MR conditional information to the labeling for the predicate devices, and changes in packaging, device design and etching. The subject devices are intended for use in limb salvage arthroplasty. Specific indications for use are below.

#### Intended Use and Indications for Use:

This device is indicated for:

- 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 proximal and/or distal femur and/or proximal tibia
- Valgus, varus or flexion deformities
- The salvage of previously failed surgical attempts
- A total femoral replacement construct consisting of Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
- · Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.
- · Fluted stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.

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- · The Trabecular Metal collar may be used cemented or uncemented against the bone.
- All other constructs are for cemented use only.

### Summary of Technological Characteristics:

The rational for substantial equivalence is based on consideration of the following characteristics:

- Intended Use: Identical to predicate
- Indications for Use: Identical to predicate ●
- Material: Identical to predicate
- Design Features: Similar to predicate ●
- Sterilization: Identical to predicate ●

#### Summary of Performance Data (Nonclinical and/or Clinical)

### Non-Clinical Tests:

- Zimmer has performed non-clinical Magnetic O Resonance Imaging (MRI) studies on implants which are determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Tests included the following:
- RF-induced heating (ASTM F2182-11a)
- Image Artifact (ASTM F2119-07)
- Magnetic Displacement (ASTM 2052-15)
- Magnetically Induced Torque (ASTM F2213-17) ●
- Finite Element Analysis (FEA) for implant stress O
- Fatigue strength testing per internal test method O
- Packaging testing (ISO 11607-1) O
- Biocompatibility (ISO 10993) O
- Bacterial Endotoxin Test (BET) per ANSI/AAMI ST o 72:2011as part of cleaning validation demonstrating implants meet the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter <161> Medical Devices - Bacterial Endotoxin and Pyrogen Tests.

### Clinical Tests:

Clinical data was not provided for the subject devices.

### Substantial Equivalence Conclusion

Non-clinical tests provided in this Traditional 510(k) establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR)

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environment, as well as any differences do not raise new questions of safety and effectiveness. The subject devices are substantially equivalent to the legally marketed predicated devices.