(437 days)
Not Found
No
The summary describes a limb salvage arthroplasty device and its mechanical and material properties, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for conditions like knee instability, bone loss, ligament deficiencies, and deformities, which are pathological states. Its purpose is to salvage previously failed surgical attempts and replace anatomical structures, suggesting it is intended to treat or mitigate diseases, injuries, or conditions, thereby acting as a therapeutic device.
No
This device is a prosthetic implant for limb salvage arthroplasty, which is a treatment, not a diagnostic procedure. The indications for use describe conditions the device treats, not conditions it diagnoses.
No
The device description and performance studies clearly indicate this is a physical implant (limb salvage arthroplasty components) and not a software-only device. The studies focus on material properties, MRI compatibility, and mechanical testing of the implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes a surgical implant for limb salvage arthroplasty, addressing structural issues in the knee and hip due to various conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as an implant for limb salvage arthroplasty, which is consistent with a surgical device.
- No mention of in vitro testing: There is no mention of the device being used to examine specimens (blood, tissue, urine, etc.) outside of the body to provide diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the implant (MRI compatibility, fatigue strength, biocompatibility, etc.), which are relevant to a surgical device, not an IVD.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a condition.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KRO, JDI, LZO, LPH, KWY, LWJ, KWZ, KWL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic O Resonance Imaging (MRI)
Anatomical Site
Knee, Hip, Femur, Tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Fatigue strength testing per internal test method
- Packaging testing (ISO 11607-1)
- Biocompatibility (ISO 10993)
- 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 Medical Devices - Bacterial Endotoxin and Pyrogen Tests.
Clinical Tests:
Clinical data was not provided for the subject devices.
Key Results: Non-clinical tests provided in this Traditional 510(k) establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K070978, K081860, K101296, K110940, K150028, K183136
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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.
1800 W. Center Street
Warsaw, IN 46580
Establishment Registration Number: 1822565 | Zimmer Segmental System | K070978 | |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------|---------|
| Contact Person: | Yoriko Kobayashi
Sr. Specialist, Regulatory Affairs
Telephone: 574-372-4222
Fax: 574-372-4710 | | K081860 | |
| Date: | November 10, 2020 | | | K101296 |
| Subject Device: | Trade Name: Zimmer® Segmental System
Common Name: Knee Prosthesis,
Hip Prosthesis | | | K110940 |
| | Classification Name:
• KRO -Prosthesis, Knee, Femorotibial, Constrained,
Cemented, Metal/Polymer (21 CFR 888.3510)
• JDI - Prosthesis, Hip, Semi-Constrained,
Metal/Polymer, Cemented (21 CFR 888.3350)
• LZO - Prosthesis, Hip, Semi-Constrained,
Metal/Ceramic/Polymer, Cemented Or Non-Porous,
Uncemented (21 CFR 888.3353)
• LPH - Prosthesis, Hip, Semi-Constrained,
Metal/Polymer, Porous Uncemented (21 CFR
888.3358)
• KWY - Prosthesis, Hip, Hemi-, Femoral,
Metal/Polymer, Cemented Or Uncemented (21 CFR
888.3390)
• LWJ - Prosthesis, Hip, Semi-Constrained,
Metal/Polymer, Uncemented (21 CFR 888.3360)
• KWZ - Prosthesis, Hip, Constrained, Cemented Or
Uncemented, Metal/Polymer (21 CFR 888.3310)
• KWL - Prosthesis, Hip, Hemi-, Femoral, Metal (21
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.
5
- · 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 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)
6
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.