(256 days)
This femoral stem is for total or hemi-hip arthroplasty and is indicated for the following conditions; Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory degenerative joint disease (I.D), e.g., rheumatoid arthritis; those patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled pattents with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
This stem is for uncemented use only.
The Zimmer Porolock MIS Stem is a modular femoral stem intended for total or hemi-hip arthroplasty. The curved, uncemented stem and is coated proximally with Titanium Vacuum Plasma Sprayed (Ti-VPS) and rough-blasted distally. The 12/14 femoral stem is available in multiple sizes in order to address different patient morphologies.
The provided documentation for the Zimmer® Porolock™ MIS Stem (K071723) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study proving device performance against those criteria.
Therefore, the requested information regarding specific acceptance criteria, a standalone study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment cannot be fully extracted from this document.
The document states: "Non-clinical testing demonstrated that the Zimmer Porolock MIS Stem met performance requirements and is as safe and effective as the predicate devices," but it does not specify what those performance requirements (acceptance criteria) were or detail the study methodology.
Here's what can be gathered, with caveats for missing information:
1. Table of Acceptance Criteria and Reported Device Performance
Cannot be fully provided as the specific acceptance criteria (performance requirements) and detailed results are not disclosed in this 510(k) summary.
The document generally states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meeting performance requirements (unspecified) | Met performance requirements (unspecified) |
| As safe as predicate devices (unspecified safety metrics) | As safe as predicate devices (unspecified safety metrics) |
| As effective as predicate devices (unspecified effectiveness metrics) | As effective as predicate devices (unspecified effectiveness metrics) |
Note: The 510(k) process relies on demonstrating substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as the predicate device(s) for the same intended use. The "acceptance criteria" here are inherently tied to the performance of those predicate devices, but the specific metrics are not elaborated upon.
Missing Information from the Document:
Due to the nature of a 510(k) summary, the following information is not provided:
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable, as no human-read test set requiring ground truth establishment is described for a medical imaging AI device. This device is a hip implant, for which "ground truth" would relate to its physical and biomechanical properties.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
5. 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
- MRMC Study: No, this is not an AI/medical imaging device. It is a hip implant.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable for a hip implant. The performance assessed would be for the physical device itself (e.g., mechanical properties, wear, corrosion). The document states "Non-clinical testing demonstrated that the Zimmer Porolock MIS Stem met performance requirements," which implies standalone testing of the device's physical properties.
7. The type of ground truth used
- Type of Ground Truth: For a hip implant, "ground truth" would typically refer to established engineering standards, material specifications, and biomechanical test results (e.g., fatigue life, static strength, wear rates compared to benchmarks). The document does not detail the specific "ground truth" or reference standards used for the "non-clinical testing."
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning product that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
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1071723
Summary of Safety and Effectiveness
| Submitter: | Zimmer GmbHSulzer Allee 8Winterthur, Switzerland CH-8404 |
|---|---|
| Contact Person: | Dalene T. Binkley, MS, RACSenior Associate, Corporate Regulatory AffairsTelephone: 574-372-4907Fax: (574) 372-4605 |
| Date: | September 24, 2007 |
| Trade Name: | Zimmer® Porolock" MIS Stem |
| Common Name: | Total Hip Prosthesis |
| Classification Name and Reference: | 1. KWA - Hip joint metal/metal semi-constrainedwith uncemented acetabular shell, 21 CFR § 888.33302. JDL - Hip joint metal/metal semi-constrainedwith cemented acetabular shell, 21 CFR § 888. 33203. LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncementedprosthesis, 21 CFR § 888.33534. KWY - Hip joint femoral (hemi-hip)metal/polymer cemented or uncemented prosthesis,21 CFR § 888.33905. KWL - Hip joint femoral (hemi-hip) metalliccemented or uncemented prosthesis, 21 CFR §888.33606. LWJ - Hip joint femoral (hemi-hip) metalliccemented or uncemented prosthesis, 21 CFR §888.33507. JDI - Hip joint metal/polymer semi-constrainedcemented prosthesis, 21 CFR § 888.33108. KWZ - Hip joint metal/polymer constrainedcemented or uncemented prosthesis, 21 CFR §888.33 |
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| Predicate Device: | Zimmer M/L Taper Hip Prosthesis, manufacturedby Zimmer, Inc., K032726, cleared October 22,2003.Durom® Acetabular Component and Metasul®LDH™ Large Diameter Heads, manufactured byZimmer GmbH, K053536, cleared March 16, 2006.Alloclassic® Zweymueller® SL/SLL Femoral Stem,manufactured by Zimmer GmbH, K030373, clearedMarch 6, 2003. |
|---|---|
| Device Description: | The Zimmer Porolock MIS Stem is a modularfemoral stem intended for total or hemi-hiparthroplasty. The curved, uncemented stem and iscoated proximally with Titanium Vacuum PlasmaSprayed (Ti-VPS) and rough-blasted distally. The12/14 femoral stem is available in multiple sizes inorder to address different patient morphologies. |
| Intended Use: | This femoral stem is for total or hemi-hiparthroplasty and is indicated for the followingconditions:Patient conditions of noninflammatory degenerativejoint disease (NIDJD), e.g., avascular necrosis,osteoarthritis, and inflammatory degenerative jointdisease (IJD), e.g., rheumatoid arthritis;Those patients with failed previous surgery wherepain, deformity, or dysfunction persists;Revision of previously failed hip arthroplasty.Total hip replacements may be considered foryounger patients if any unequivocal indicationoutweighs the risks associated with the age of thepatient and modified demands regarding activityand hip joint loading are assured. This includesseverely crippled patients with multiple jointinvolvement, for whom an immediate need of hipmobility leads to an expectation of significantimprovement in the quality of their lives. |
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Comparison to Predicate Device:
The Zimmer Porolock MIS Stem is packaged, manufactured, and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use and fixation methods as the predicate devices.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
.
:
: :
Non-clinical testing demonstrated that the Zimmer Porolock MIS Stem met performance requirements and is as safe and effective as the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 7 2008
Zimmer GmbH % Ms. Dalene T. Binkley Senior Associate, Warsaw Regulatory Affairs P.O. Box 708 Warsaw, IN 46581-0708
Re: K071723 Trade/Device Name: Zimmer® Porolock® MIS Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, KWZ, JDL, LZO, KWY, KWL, LWJ, JDI Dated: March 3, 2008 Received: March 4, 2008
Dear Ms. Binkley:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Dalene Binkley
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 you 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 Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K071723 Indications for Use
510(k) Number (if known):
Device Name:
Zimmer® Porolock® MIS Stem
Indications for Use:
This femoral stem is for total or hemi-hip arthroplasty and is indicated for the following conditions; Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory degenerative joint disease (I.D), e.g., rheumatoid arthritis; those patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled pattents with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
This stem is for uncemented 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)
Nil rella fr mxn
Division of Gene I, Restorative. and Neurological Devices
510(k) Number K671723
Page 1 of 1
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§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.