(88 days)
- 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.
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.
Here's an analysis of the provided text regarding the Zimmer® Segmental System, focusing on acceptance criteria and the study proving it:
It's important to note that the provided documentation is a 510(k) premarket notification summary for a medical device. This type of submission relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials with predefined acceptance criteria for novel device performance.
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for a 510(k) typically refers to demonstrating that the new device is as safe and effective as its predicate. For the Zimmer® Segmental System, the core acceptance criterion is substantial equivalence to the predicate devices. The performance data presented focuses on justifying this equivalence.
| Acceptance Criterion (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Device is safe and effective as the predicate device | Non-Clinical Performance: "The results of non-clinical (lab) performance testing demonstrate that the device is safe and effective." |
| Identical intended use as the predicate device | "This device also has the same intended use as predicate devices." |
| Similar technological characteristics to the predicate device | "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." "The device shares a similar fixation method as the predicate devices." "This device is packaged, manufactured and sterilized using the same materials and processes as the predicate devices." (Note: A specific difference in fixation with the Trabecular Metal collar is acknowledged but not presented as a non-conformance, implying the non-clinical testing addressed it.) |
Study Details
The document states: "Clinical data were not needed for this device." This is a critical piece of information. Therefore, many of the typical questions for a clinical study involving AI or novel technology are not applicable here. The "study" proving the device meets acceptance criteria is primarily non-clinical (lab) performance testing.
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document only mentions "non-clinical (lab) performance testing." Details on the number of components, configurations, or test repetitions are not provided in this summary.
- Data Provenance: Not specified, but implied to be from Zimmer, Inc.'s internal or contracted lab testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. Since no clinical data or human interpretation was used to establish ground truth for a test set, there were no experts involved in this capacity. The "ground truth" for non-clinical testing would be measured physical properties (e.g., strength, fatigue life) against established engineering standards or predicate device performance.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication of a test set (e.g., images for diagnosis) was performed as clinical data was not used.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI device, and no MRMC study or AI assistance was involved.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical knee prosthesis, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" would be engineering specifications, material properties, and mechanical performance standards relevant to orthopedic implants. Comparisons would likely have been made to the performance characteristics of the predicate devices under similar testing conditions.
-
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device, so there is no training set in that context. If "training set" refers to design and development iterations, that information is not provided.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set in the AI/ML sense, this question does not apply.
Summary of the "Study" Proving Acceptance Criteria:
The Zimmer® Segmental System received 510(k) clearance based on non-clinical (lab) performance testing which demonstrated the device is "safe and effective." This testing would have focused on mechanical properties, material integrity, and other engineering characteristics to show that the new device performs comparably to its predicate devices, thereby establishing substantial equivalence. No clinical studies or human-in-the-loop performance evaluations were deemed necessary for this particular submission.
{0}------------------------------------------------
K070978 (pg. 1 of 3)
Summary of Safety and Effectiveness
JUL - 3 2007
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Brandon Hipsher, RACSenior Associate, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605 |
| Date: | June 20, 2007 |
| Trade Name: | Zimmer® Segmental System |
| Common Name: | Total Knee Prosthesis |
| Classification Nameand Reference: | Knee joint, femorotibial, metal/polymer,constrained, cemented prosthesis21 CFR § 888.3510, product code KRO |
| Predicate Device: | NexGen® Complete Knee Solutions Rotating HingeKnee 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 fullyconstrained cemented knee prosthesis intended toreplace the distal femur and/or total knee in casesthat require extensive resection and restoration. TheSegmental Knee System provides for crosscompatibility between selected components fromthe MOST System and the NexGen Rotating HingeKnee Systems. When used with MOST Systemproximal femur and NexGen Rotating Hinge Kneetibial baseplates, a total mid-calf to hip replacementcan be achieved. The distal femoral componentsare designed to be compatible with all currentNexGen 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
§ 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.