(87 days)
General Indications for the Segmental System:
- 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
Indications specific to the Variable Stiffness Stem extensions:
- Variable Stiffness stem extensions require the t 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, but the remainder of the stem must be used uncemented.
The Variable Stiffness Stem extensions are intended to be used in the proximal and mid-shaft portion of the femur. They are available in either straight or bowed geometry and are made from Zimaloy™ Cobalt-Chromium-Molybdenum Alloy.
The Intercalary Segments are intended for the replacement of the mid-shaft portion of the femur or for use as a segment connected to other Zimmer® Segmental System components. They are made from Tivanium™ Ti-6Al-4V Alloy.
The provided text describes the Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments, a total hip prosthesis. The information focuses on its regulatory clearance (K081860) and comparison to predicate devices. However, it explicitly states:
"Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective."
"Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
This indicates that the acceptance criteria were based on non-clinical (lab) performance testing, and no clinical study was conducted or required for this 510(k) clearance. Therefore, a direct answer to some of the requested points, particularly those related to a clinical study, cannot be provided from the given document.
Here's the breakdown of the available information:
Acceptance Criteria and Device Performance
Since clinical data was not required, the acceptance criteria and performance are based on non-clinical (lab) testing comparing the device to its predicate devices. The document implies that the device met these non-clinical criteria by stating: "Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety | Demonstrated as safe through non-clinical (lab) performance testing. |
| Effectiveness | Demonstrated as effective through non-clinical (lab) performance testing. |
| Manufacturing/Sterilization | Manufactured, packaged, and sterilized using the same materials and processes as the predicate devices. |
| Intended Use | Has the same intended use as the predicate devices. |
| Fixation Methods | Has the same fixation methods as the predicate devices. |
| Material Composition | Stem extensions: Zimaloy™ Cobalt-Chromium-Molybdenum Alloy. Intercalary Segments: Tivanium™ Ti-6Al-4V Alloy. (These materials are implicitly accepted as safe and effective, likely based on predicate device history and material biocompatibility standards). |
Detailed Information Regarding the Study (where applicable from provided text)
-
Sample size used for the test set and the data provenance: Not applicable, as clinical studies with patient test sets were not performed or required. The testing referred to as "non-clinical (lab) performance testing" would involve mechanical or material samples, not human subjects.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring human expert ground truth was used.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication was 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 device is a physical medical implant, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical implant.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical (lab) performance testing, the ground truth would likely be based on established engineering benchmarks, material science standards, and performance characteristics of the predicate devices, rather than clinical outcomes or expert consensus on patient data.
-
The sample size for the training set: Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set in that context.
-
How the ground truth for the training set was established: Not applicable, as per point 7.
{0}------------------------------------------------
SEP 2 6 2008
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Daniel J. WillimanSpecialist, Regulatory AffairsTelephone: (574) 371-8065Fax: (574) 372-4605 |
| Date: | September 24, 2008 |
| Trade Name: | Zimmer® Segmental System Variable StiffnessStem Extensions and Intercalary Segments |
| Common Name: | Total Hip Prosthesis |
| Classification Nameand Reference: | Hip joint, metal/ceramic/polymer, semi-constrained,cemented or nonporous uncemented prosthesis.21 CFR § 888.3353 |
| Predicate Devices: | Zimmer Segmental System, manufactured byZimmer, Inc. (K070978, cleared July 03, 2007);MOST System, manufactured by IntermedicsOrthopedics, Inc. (K960626, cleared April 18, 1996and K973087, cleared November 14, 1997);Orthogenesis LPS System Intercalary,manufactured by DePuy, Inc. (K003182, clearedJune 27, 2001) |
| Device Description: | The Variable Stiffness Stem extensions are intendedto be used in the proximal and mid-shaft portion ofthe femur. They are available in either straight orbowed geometry and are made from Zimaloy™Cobalt-Chromium-Molybdenum Alloy.The Intercalary Segments are intended for thereplacement of the mid-shaft portion of the femur orfor use as a segment connected to other Zimmer®Segmental System components. They are made. |
{1}------------------------------------------------
p.2/2
from Tivanium™ Ti-6Al-4V Alloy.
General Indications for the Segmental System:
- 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
Indications specific to the Variable Stiffness Stem extensions:
- Variable Stiffness stem extensions require the t 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, but the remainder of the stem must be used uncemented.
These devices are manufactured, packaged and sterilized using the same materials and processes as the predicate devices. They also have the same intended use and fixation methods as the predicate devices.
Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
SEP 2 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. c/o Daniel J. Williman Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K081860 Trade/Device Name: Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: June 30, 2008 Received: July 1, 2008
Dear Mr. Williman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
{3}------------------------------------------------
Page 2 - Daniel J. Williman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melham
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K08186U
Indications for Use
510(k) Number (if known):
Device Name:
Segmental Variable Stiffness Stems and Intercalary Segments
Indications for Use:
General Indications for the Segmental System:
- · This device is indicated for:
- Moderate to severe knee instability t
- । Significant bonc loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, collagen disorders, and/or avascular necrosis of the femoral condyle
- Valgus, varus or flexion deformities -
- The salvage of previously failed surgical attempts ---
Indications specific to the Variable Stiffness Stem extensions:
- · Variable Stiffness stem extensions require the usc of cither 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, but the remainder of the stem must be used uncemented.
Mark N. Mellers
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
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)
Page 1 of 1
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.