(29 days)
Not Found
No
The 510(k) summary describes a mechanical hip stem and associated surgical rasps. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are non-clinical and focus on usability and device analysis, not algorithmic performance.
No.
The device is a femoral stem used in hip arthroplasty, which is an implant to replace a joint, not a device that directly administers therapy or treatment.
No
The device described is a femoral stem used for hip arthroplasty, and the rasps are for preparing the femoral canal for the stem. Its function is to replace or improve a hip joint, not to diagnose a condition.
No
The device description clearly states it is a femoral stem and associated surgical rasps, which are physical hardware components used in hip arthroplasty.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "femoral stem" and "rasps" used for "total hip or hemi-hip arthroplasty." These are surgical implants and instruments used in the body during a surgical procedure.
- Intended Use: The intended use describes the conditions for which the hip replacement surgery is performed, not a diagnostic test.
- No Mention of Samples or Testing: There is no mention of analyzing samples from the body or performing any kind of diagnostic test.
Therefore, based on the provided information, this device is a surgical implant and associated instruments, not an In Vitro Diagnostic.
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:
• Non-inflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· 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 patients 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.
Product codes (comma separated list FDA assigned to the subject device)
KWY, KWZ, JDI, LZO, LWJ, KWL
Device Description
The Fitmore Hip 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.
No changes are being made to the Fitmore Hip Stems themselves, a line extension to the rasps provided to facilitate implantation of the Fitmore Hip Stem is being proposed in this submission.
The rasps that are subject of this submission are intended to prepare the femoral canal for final implantation of the stem. They are made of Stainless Steel and are sized relative to the intended Fitmore Stem implant beginning with the starter rasp and becoming progressively larger in order that the femoral canal created by the rasps is sized appropriately to the pre-operative templated size of stem with the created canal also providing the required femoral stability
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint / femoral canal
Indicated Patient Age Range
younger patients, severely crippled patients with multiple joint involvement
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: The results of non-clinical performance testing and analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance analyses included: 1. Usability Testing 2. Similar Device Analysis
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.
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
February 7, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer GmbH Thomas Lincoln Senior Regulatory Affairs Specialist Sulzerallee 8. P.O. Box 8404 Winterthur. Switzerland
Re: K170072
Trade/Device Name: Fitmore Hip Stem Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY, KWZ, JDI, LZO, LWJ, KWL Dated: January 3. 2017 Received: January 9, 2017
Dear Thomas Lincoln:
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. 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K170072 Not yet known (submitted as a Special 510(k) to K071723)
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:
• Non-inflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· 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 patients 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.
Type of Use (Select one or both, as applicable)
X 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 features a large, stylized blue letter "Z" enclosed in a blue circle. Below the circle, the word "zimmer" is written in a lowercase, sans-serif blue font.
510(k) Summary
| Sponsor: | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Lincoln
Senior Specialist, Regulatory Affairs
Telephone: +41 5885 48 257
Fax: + 41 5224 48 658 |
| Date: | 03rd January, 2017 |
| Subject Device: | Trade Name: Fitmore® Hip Stem
Common Name: Hip Prosthesis |
| Classification Product Code /
Device Classification Name: | KWY - Prosthesis, hip, hemi-, femoral,
metal/polymer, cemented or uncemented
KWZ - Prosthesis, hip, constrained, cemented or
uncemented, metal/polymer
JDI - Prosthesis, hip, semiconstrained,
metal/polymer, cemented
LZO - Prosthesis, hip, semiconstrained,
metal/ceramic/polymer, cemented or nonporous,
uncemented
LWJ - Prosthesis, hip, semiconstrained, metal
polymer, uncemented
KWL - Prosthesis, hip, hemi-, femoral, metal |
| Regulation Number / Description: | 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 § 888.3350 Hip joint metal/polymer semi-
constrained cemented prosthesis
21 CFR § 888.3353 Hip joint metal/ceramic/polymer
semi-constrained cemented or nonporous uncemented
prosthesis.
21 CFR § 888.3360 Hip joint femoral (hemi-hip)
metallic cemented or uncemented prosthesis |
| | 21 CFR § 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis |
| Predicate Device: | Fitmore Hip Stem, manufactured by Zimmer GmbH, K071723, cleared March 7, 2008 (as Zimmer Porolock MIS Stem). |
| Device Description: | The Fitmore Hip 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.
No changes are being made to the Fitmore Hip Stems themselves, a line extension to the rasps provided to facilitate implantation of the Fitmore Hip Stem is being proposed in this submission.
The rasps that are subject of this submission are intended to prepare the femoral canal for final implantation of the stem. They are made of Stainless Steel and are sized relative to the intended Fitmore Stem implant beginning with the starter rasp and becoming progressively larger in order that the femoral canal created by the rasps is sized appropriately to the pre-operative templated size of stem with the created canal also providing the required femoral stability |
| Intended Use: | This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
Non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. Failed previous surgery where pain, deformity, or dysfunction persists |
4
- Revision of previously failed hip arthroplasty. .
5
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 patients 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 Fitmore Hip Stem implants are not modified as Comparison to Predicate Device: compared to their predicates. The Fitmore Hip Stem implants are identical in intended use, materials, sterility, and performance characteristics to the predicate devices and remain unchanged. Instead, an additional rasp variant is introduced; these rasps are dimensionally larger than the currently available rasps and in all other aspects (intended use, materials, sterility, and performance characteristics) the proposed rasps are identical to the predicate rasps. Performance Data (Nonclinical Non-Clinical Performance and Conclusions: and/or Clinical): The results of non-clinical performance testing and analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance analyses included: 1. Usability Testing 2. Similar Device Analysis
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.