(78 days)
This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
• Noninflammatory degenerative joint disease (NIDJD), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.
• Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
• Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.
This stem is for uncemented use only.
The Fitmore® Hip Stem is a modular femoral stem intended for total or hemi-hip arthroplasty. The component is an uncemented stem which is coated proximally with Titanium Vacuum Plasma Spray and rough-blasted distally for primary stability. The stem design is curved and features a trapezoidal cross-section.
The 12/14 femoral stem is available in multiple sizes, consisting of three stem families. The different family designs were developed in order to meet various patients' anatomic needs. As the anatomic offset varies considerably between individuals, the Fitmore® Hip Stem offers a wide range of offset options. Each family is designed with a CCD angle of 140°, 137°, 129° and 127°.
This document is a 510(k) premarket notification for a medical device called the "Fitmore Hip Stem." It concerns the substantial equivalence of the device to legally marketed predicate devices.
Based on the provided text, the device is a hip implant, and the performance data described is focused on non-clinical aspects like packaging and sterilization, not on the clinical performance or diagnostic accuracy of an AI or software-as-a-medical-device (SaMD) product.
Therefore, most of the requested information regarding acceptance criteria, study methodologies (sample size, expert ground truth, adjudication, MRMC, standalone performance), and training set details for AI/SaMD devices is not applicable to this document. This document is for a physical orthopedic implant.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical performance testing for packaging and labeling integrity. It does not provide specific quantitative acceptance criteria or performance metrics in a table format that would be typical for an AI/SaMD product.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Packaging configuration maintains integrity of the sterile barrier system up to the point of use. | Verified to maintain integrity of the sterile barrier system. |
| Packaging provides adequate protection to the product through hazards of sterilization, handling, distribution, and storage according to ISO 11607-1:2009 and ISO 11607-2:2006. | Verified to provide adequate protection. |
| Labels and IFU (Instructions For Use) remain intact and legible. | Verified to remain intact and legible. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "representative worst-case products" were used for packaging configuration testing, but no specific sample size (N) is provided.
- Data Provenance: Not applicable in the context of clinical data for a physical implant. The testing was conducted by the manufacturer (Zimmer GmbH). The document implies the tests are laboratory-based, not patient-derived data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The "ground truth" for a physical implant's packaging integrity is based on testing against ISO standards, not expert medical opinion on imaging or diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., radiologist reads) in clinical studies, not for objective engineering tests of packaging.
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:
This information is not applicable. This device is a physical hip stem, not an AI or software product. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical performance (packaging) was based on compliance with international standards (ISO 11607-1:2009 and ISO 11607-2:2006) and physical integrity. No expert consensus, pathology, or outcomes data were used for this type of testing.
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
In summary: The provided document is an FDA 510(k) clearance letter for a conventional medical device (a hip stem), not a software or AI-driven diagnostic/therapeutic device. Therefore, the questions related to AI/SaMD performance metrics and study methodologies are generally not relevant to the content of this document.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
December 11, 2019
Zimmer GmbH Tobias Moller Regulatory Affairs Specialist Sulzer Allee 8 WINTERTHUR CH 8404
Re: K192236
Trade/Device Name: Fitmore Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, KWL, KWY, KWZ, LWJ, LZO Dated: October 2, 2019 Received: October 7, 2019
Dear Tobias Moller:
This letter corrects our substantially equivalent letter of November 5, 2019.
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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vesa Vuniqi Date: 2019.12.11 -5
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K192236
Device Name Fitmore® Hip Stem
Indications for Use (Describe)
This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
· Noninflammatory degenerative joint disease (NID), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.
· Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
· Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.
This stem is for uncemented 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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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. Below the company name is the tagline "Your progress. Our promise." in a smaller font size.
| Sponsor: | Zimmer GmbH |
|---|---|
| Sulzerallee 8, P.O. Box | |
| 8404 Winterthur, Switzerland | |
| Contact Person: | Tobias Möller |
| Specialist, Regulatory Affairs | |
| Telephone: +41 58 854 89 94 | |
| Fax: +41 52 244 86 58 | |
| Date: | October 18, 2019 |
| Trade Name: | Fitmore® Hip Stem |
| Common or Usual Name: | Hip Prosthesis |
| Classification Product Code: | JDI, KWL, KWY, KWZ, LWJ, LZO |
| Device Classification Name: | Prosthesis, Hip, Semi-Constrained (Metal Uncemented AcetabularComponent) |
| Regulation Number / Description: | 21 CFR § 888.3350 - Hip joint metal/polymer semi-constrainedcemented prosthesis |
| 21 CFR § 888.3360 - Hip joint femoral (hemi-hip) metalliccemented or uncemented prosthesis | |
| 21 CFR § 888.3390 – Hip joint femoral (hemi-hip) metal/polymercemented or uncemented prosthesis | |
| 21 CFR § 888.3310 - Hip joint metal/polymer constrainedcemented or uncemented prosthesis | |
| 21 CFR § 888.3360 – Hip joint femoral (hemi-hip) metalliccemented or uncemented prosthesis | |
| 21 CFR § 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis | |
| Predicate Device: | Fitmore® Hip Stem, manufactured by Zimmer GmbH, K071723,cleared March 7, 2008 |
| Device Description: | The Fitmore® Hip Stem is a modular femoral stem intended fortotal or hemi-hip arthroplasty. The component is an uncementedstem which is coated proximally with Titanium Vacuum PlasmaSpray and rough-blasted distally for primary stability. The stemdesign is curved and features a trapezoidal cross-section. |
| The 12/14 femoral stem is available in multiple sizes, consisting ofthree stem families. The different family designs were developedin order to meet various patients' anatomic needs. As theanatomic offset varies considerably between individuals, theFitmore® Hip Stem offers a wide range of offset options. Eachfamily is designed with a CCD angle of 140°, 137°, 129° and 127°. | |
| Indications for Use: | This femoral stem is for total hip or hemi-hip arthroplasty and isindicated for the following conditions:• Noninflammatory degenerative joint disease (NIDJD), e. g.,avascular necrosis, osteoarthritis and inflammatory jointdisease (IJD), e. g., rheumatoid arthritis.• Failed previous hip surgery (not THA) where pain, deformity ordysfunction persists.• Optional use in revision: in some medical conditions (e. g.,early revision when healthy and good bone stock exists) thesurgeon may opt to use primary implants in a revisionprocedure.This stem is for uncemented use only. |
| Comparison to Predicate Device: | The intended use of the proposed device is identical to those ofthe previously cleared predicate device. The amount of indicationsfor use have been reduced and reworded for more claritycompared to the previously cleared device. The proposedchanges do not alter the fundamental scientific technology sharedby both the proposed and predicate devices. Zimmer GmbH isfurthermore seeking clearance for minor modifications that havebeen implemented since the last clearance. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Packaging performance testing was to verify that packagingconfiguration maintains integrity of the sterile barrier system up tothe point of use and provides adequate protection to the productthrough the hazards of sterilization, handling, distribution andstorage according to ISO 11607-1:2009 and ISO 11607-2:2006.Performance testing further verified that labels and IFU remainintact and legible. Packaging Configuration testing was conductedby representative worst-case products.Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device. |
| Conclusion | The subject device has the same intended use and similarindications for use as the predicate device. The subject deviceuses the same operating principle, incorporates the same basicdesign and labeling and is manufactured and sterilized using thesame materials and processes as the predicate device. Except forthe modifications described in this submission the subject deviceis identical to the predicate device and the performance data andanalyses demonstrate that:• any differences do not raise new questions of safety andeffectiveness as established with performance testing; and• the subject devices are at least as safe and effective as thelegally marketed predicate devices. |
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Image /page/4/Picture/1 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. Below the company name is the tagline "Your progress. Our promise." in a smaller font size.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.