(78 days)
Not Found
No
The summary describes a mechanical implant (femoral stem) and its physical characteristics, materials, and intended use. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a femoral stem used in hip arthroplasty to treat conditions like degenerative joint disease and failed hip surgeries, which directly addresses medical conditions and aims to restore function or alleviate symptoms, making it a therapeutic device.
No
The device is a femoral stem used in hip replacement surgery to treat conditions like degenerative joint disease, not to diagnose them.
No
The device description clearly describes a physical implant (femoral stem) made of materials like Titanium, intended for surgical implantation. It is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that this is a femoral stem for total hip or hemi-hip arthroplasty, used to replace a joint in the body.
- Device Description: The description details a physical implantable device (a femoral stem) made of metal with specific coatings and design features.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests.
This device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JDI, KWL, KWY, KWZ, LWJ, LZO
Device Description
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°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-Clinical Performance and Conclusions:
Packaging performance testing was to verify that packaging configuration maintains integrity of the sterile barrier system up to the point of use and provides adequate protection to the product through the hazards of sterilization, handling, distribution and storage according to ISO 11607-1:2009 and ISO 11607-2:2006. Performance testing further verified that labels and IFU remain intact and legible. Packaging Configuration testing was conducted by representative worst-case products.
Clinical Performance and Conclusions:
Clinical data and conclusions 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.
Fitmore® Hip Stem, manufactured by Zimmer GmbH, K071723
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
§ 888.3390 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.
0
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.
1
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
2
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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3
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 Acetabular |
| Component) | |
| Regulation Number / Description: | 21 CFR § 888.3350 - Hip joint metal/polymer semi-constrained |
| cemented prosthesis | |
| 21 CFR § 888.3360 - Hip joint femoral (hemi-hip) metallic | |
| cemented or uncemented prosthesis | |
| 21 CFR § 888.3390 – Hip joint femoral (hemi-hip) metal/polymer | |
| cemented or uncemented prosthesis | |
| 21 CFR § 888.3310 - Hip joint metal/polymer constrained | |
| cemented or uncemented prosthesis | |
| 21 CFR § 888.3360 – Hip joint femoral (hemi-hip) metallic | |
| cemented 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 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°. | |
| Indications for Use: | 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. | |
| Comparison to Predicate Device: | The intended use of the proposed device is identical to those of |
| the previously cleared predicate device. The amount of indications | |
| for use have been reduced and reworded for more clarity | |
| compared to the previously cleared device. The proposed | |
| changes do not alter the fundamental scientific technology shared | |
| by both the proposed and predicate devices. Zimmer GmbH is | |
| furthermore seeking clearance for minor modifications that have | |
| been implemented since the last clearance. | |
| Performance Data (Nonclinical | |
| and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Packaging performance testing was to verify that packaging | |
| configuration maintains integrity of the sterile barrier system up to | |
| the point of use and provides adequate protection to the product | |
| through the hazards of sterilization, handling, distribution and | |
| storage according to ISO 11607-1:2009 and ISO 11607-2:2006. | |
| Performance testing further verified that labels and IFU remain | |
| intact and legible. Packaging Configuration testing was conducted | |
| by 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 similar |
| indications for use as the predicate device. The subject device | |
| uses the same operating principle, incorporates the same basic | |
| design and labeling and is manufactured and sterilized using the | |
| same materials and processes as the predicate device. Except for | |
| the modifications described in this submission the subject device | |
| is identical to the predicate device and the performance data and | |
| analyses demonstrate that: | |
| • any differences do not raise new questions of safety and | |
| effectiveness as established with performance testing; and | |
| • the subject devices are at least as safe and effective as the | |
| legally 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.