(88 days)
Not Found
No
The document describes a mechanical knee prosthesis and does not mention any AI or ML components or functions.
Yes
The device is a knee prosthesis intended to replace parts of or the entire knee and femur in cases requiring extensive resection and restoration, which is a therapeutic intervention.
No.
The device is a knee prosthesis intended for replacement, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical knee prosthesis, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a "fully constrained cemented knee prosthesis intended to replace the distal femur and/or total knee". This is a surgical implant, not a diagnostic test performed on a sample.
- Intended Use: The intended use describes the conditions for which the prosthesis is indicated (knee instability, bone loss, deformities, salvage of failed surgeries). These are all related to the structural and functional issues of the knee joint, not the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic device.
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, 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
- A total femoral replacement construct consisting of MOST Options proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
- 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 and 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 as long as the remainder of the stem extension is cemented.
- All other constructs are for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KRO, JDI, LZO
Device Description
The Zimmer® Segmental System is a fully constrained cemented knee prosthesis intended to replace the distal femur and/or total knee in cases that require extensive resection and restoration. The Segmental Knee System provides for cross compatibility between selected components from the MOST System and the NexGen Rotating Hinge Knee Systems. When used with MOST System proximal femur and NexGen Rotating Hinge Knee tibial baseplates, a total mid-calf to hip replacement can be achieved. The distal femoral components are designed to be compatible with all current NexGen patella components. The Segmental System is a modular system comprised of fluted stem extensions, segments, articular surfaces and distal femoral components. The prosthesis is designed to be used with NexGen patellar and tibial components as well as the MOST System proximal femoral component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, distal femur, 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)
The results of non-clinical (lab) performance testing demonstrate that the device is safe and effective. Clinical data 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
K070978 (pg. 1 of 3)
Summary of Safety and Effectiveness
JUL - 3 2007
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher, RAC
Senior Associate, Corporate Regulatory Affairs
Telephone: (574) 371-8083
Fax: (574) 372-4605 |
| Date: | June 20, 2007 |
| Trade Name: | Zimmer® Segmental System |
| Common Name: | Total Knee Prosthesis |
| Classification Name
and Reference: | Knee joint, femorotibial, metal/polymer,
constrained, cemented prosthesis
21 CFR § 888.3510, product code KRO |
| Predicate Device: | NexGen® Complete Knee Solutions Rotating Hinge
Knee Systems, manufactured by Zimmer, Inc.,
K013385, cleared January 9, 2002.
Modular Options for Severe Bone Loss and Trauma
(MOST®) System, manufactured by Zimmer Inc.,
K002324, cleared August 24, 2000. |
| Device Description: | The Zimmer® Segmental System is a fully
constrained cemented knee prosthesis intended to
replace the distal femur and/or total knee in cases
that require extensive resection and restoration. The
Segmental Knee System provides for cross
compatibility between selected components from
the MOST System and the NexGen Rotating Hinge
Knee Systems. When used with MOST System
proximal femur and NexGen Rotating Hinge Knee
tibial baseplates, a total mid-calf to hip replacement
can be achieved. The distal femoral components
are designed to be compatible with all current
NexGen patella components. |
.
1
K070978 (pg. 2 of 3)
The Segmental System is a modular system comprised of fluted stem extensions, segments, articular surfaces and distal femoral components. The prosthesis is designed to be used with NexGen patellar and tibial components as well as the MOST System proximal femoral component.
This device is indicated for:
- ー Moderate to severe knee instability
- l 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
- i Valgus, varus or flexion deformities
- -The salvage of previously failed surgical attempts
- · A total femoral replacement construct consisting of MOST System proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
- · 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 and 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 as long as the remainder of the stem extension is cemented.
- · All other constructs are for cemented use only.
This device is packaged, manufactured and sterilized using the same materials and processes as the predicate devices. This device also has the same intended use as predicate devices. The device shares a similar fixation method as the predicate devices. The only difference in fixation methods arise when using the Trabecular Metal stem collar, which may be used cemented or uncemented against the bone. All other constructs are for cemented use only.
Intended Use:
Comparison to Predicate Device:
2
K070978(pg 3 of 3)
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
The results of non-clinical (lab) performance testing demonstrate that the device is safe and effective.
Clinical Performance and Conclusions:
Clinical data were not needed for this device.
3
JUI - 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Mr. Brandon Hipsher, RAC Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K070978 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 Dated: April 2, 2007 Received: April 6, 2007
Dear Mr. Hipsher:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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.
If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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); good manufacturing practice requirements as set
4
Page 2 - Mr. Brandon Hipsher, RAC
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.
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours.
Kote
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer® Segmental System
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 femoral condyle
- | Valgus, varus or flexion deformities
- -The salvage of previously failed surgical attempts
- · A total femoral replacement construct consisting of MOST Options proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
- · 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 and 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 as long as the remainder of the stem extension is cemented.
- · All other constructs are for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line – Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorativ
and Neurological Devices
Number
age lof