(30 days)
Not Found
No
The document describes a mechanical orthopedic implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device replaces parts of the skeletal system (proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee) to treat conditions like knee instability, bone loss, and deformities, which directly addresses medical conditions to restore function.
No
Explanation: The device description and intended use clearly indicate that this product is a replacement system (e.g., for femur and tibia), designed for surgical restoration. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly indicates it is a physical implant system (Zimmer Segmental System) intended to replace bone segments and joints, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that this device is a surgical implant intended to replace parts of the femur, tibia, and knee. It is a physical device implanted into the body.
- Intended Use: The intended use describes conditions and situations where this implant is surgically used to restore function and stability to the knee and surrounding bones. It does not involve testing samples outside the body.
Therefore, based on the provided information, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is indicated for:
- Moderate to severe knee instability
- Sigmificant bone loss and/or ligament deficiencies caused by neoplasms, traumatoid 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 the MOST Options® or 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
Device Description
The Zimmer Segmental System is intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration. The Segmental System provides for cross compatibility between selected components from the MOST Options® System and NexGen® Rotating Hinge Knee System.
A total mid-calf to hip replacement can be achieved using the Segmental System. The cleared distal femoral and the proposed distal femoral components are designed to be compatible with standard NexGen patella components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, mid-shaft femur, distal femur, proximal tibia, total knee, mid-calf to hip
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)
Performance Data (Nonclinical Non-Clinical Performance and Conclusions): The results of non-clinical (lab) component fatigue performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are depicted in a simple, line-art style. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2015
Zimmer. Incorporated Ms. Yoriko Kobayashi Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581
Re: K150028
Trade/Device Name: Zimmer Segmental System XT Components Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: January 6, 2015 Received: January 7, 2015
Dear Ms. 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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Yoriko Kobayashi
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Zimmer Segmental System XT Components
Indications for Use (Describe)
This device is indicated for:
- Moderate to severe knee instability
- Sigmificant bone loss and/or ligament deficiencies caused by neoplasms, traumatoid 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 the MOST Options® or 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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3
510(k) Summary
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708
Telephone: (574) 372-4803
Fax: (574) 372-4605 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoriko Kobayashi
Specialist, Regulatory Affairs
Zimmer K.K
Telephone: +81-364-026-748
Fax: (574) 372-4605 |
| Date: | January 06, 2015 |
| Trade Name: | Zimmer® Segmental System XT Components |
| Product Code / Device: | KRO - Prosthesis, Knee, Femorotibial,
Constrained, Cemented, Metal/Polymer, |
| Regulation Number / Description: | 21 CFR § 888.3510 – Knee joint femorotibial
metal/polymer constrained cemented prosthesis |
| Predicate Device: | Zimmer Segmental System, manufactured by
Zimmer, Inc., K070978, cleared July 3, 2007 |
| Device Description / Intended Use: | The Zimmer Segmental System is intended to
replace the proximal femur, mid-shaft femur, distal
femur, proximal tibia and/or total knee in cases that
require extensive resection and restoration. The
Segmental System provides for cross compatibility
between selected components from the MOST
Options® System and NexGen® Rotating Hinge
Knee System. |
| | A total mid-calf to hip replacement can be achieved
using the Segmental System. The cleared distal
femoral and the proposed distal femoral
components are designed to be compatible with
standard NexGen patella components. |
4
Indications for Use:
The proposed Segmental System XT components are identical to corresponding existing predicate Segmental System components for use in the distal femur, except for an extended boss on the polyethylene insert component and a corresponding pocket in the distal femoral component.
The Segmental System 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 the MOST Options or 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
Page 3 January 06, 2015
- The Trabecular Metal collar may be used cemented or uncemented against the bone. • All other constructs are for cemented use only. The proposed Segmental System components are Comparison to Predicate Device: similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices. Performance Data (Nonclinical Non-Clinical Performance and Conclusions: and/or Clinical): The results of non-clinical (lab) component fatigue performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.