(284 days)
Not Found
No
The description focuses on the mechanical design, materials, and physical characteristics of a femoral stem and modular neck for hip arthroplasty. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a Revision Femoral Stem intended for hip arthroplasty, which is a medical procedure used to treat a condition and restore function, hence it is a therapeutic device.
No
The document describes a Revision Femoral Stem, which is a surgical implant used in hip replacement and revision procedures. It is not a diagnostic device.
No
The device description clearly details a physical implant (femoral stem and modular neck) made of materials like Ti6Al4V and UHMWPE, intended for surgical implantation. This is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a Revision Femoral Stem, which is a surgical implant used in hip replacement surgery. It is a physical device inserted into the body to replace a damaged part of the femur.
- Intended Use: The intended use clearly states it's for "cementless revision hip arthroplasty," which is a surgical procedure.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose.
Therefore, based on the provided information, the Revision Femoral Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH, KWY
Device Description
The Revision Femoral Stem consists of a femoral stem and a modular neck, assembled together through a taper coupling stabilized by means of a safety screw. When used in total hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with modular femoral heads and compatible acetabular cups. When used in partial hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with a Lock Bipolar Head.
The stem is made of Ti6Al4V (ASTM F1472 – ISO 5832-3). The stem is straight, with a tapered profile, round finned section and a rounded tip to facilitate insertion. The external surface of the stem features a macro-roughened finishing obtained by sandblasting. Diameters ranging from 14 to 26 mm, with increases of 1 mm, for a total of 13 diameters are available. Two lengths (140 or 200 mm) for each diameter of the stem are available.
The neck is made of Ti6A14V (ASTM F1472 – ISO 5832-3). The same material is also used for the safety screw, which also has a small pin made of UHMWPE (ISO 5834-2, ASTM F648) to help prevent loosening of the safety screw. Two (2) versions of the neck are available , one with a CCD angle of 131° and another with a CCD angle of 135°. Both the neck versions are available in 7 different heights. Distally, the external surface of the neck component features a macro-roughened finishing obtained by sandblasting; proximally, the surface of the neck component is polished to reduce the chance of polyethylene wear particles if the neck accidentally rubs against the polyethylene of the acetabular component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head, neck or portions of the proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Testing: Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:
- Fatigue testing (ISO 7206-4);
- Fatigue testing (ISO 7206-6);
- Fretting evaluation:
- Analysis of disassembly torque of safety screw;
- Range of motion (ISO 21535).
LAL testing has been performed to establish that the subject device meet the specified 20EU/device limit.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of Revision Femoral Stem to the predicate 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
§ 888.3353 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a way that they appear to be interconnected. The profiles are rendered in a simple, line-art style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2017
Limacorporate S.p.A. Dr. Stephen Peoples President People & Associates- Stephen J. Peoples, VMD, MS 411 Auditorium Blvd. Winona Lake, Indiana 46590
Re: K161226
Trade/Device Name: Revision Femoral Stem 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, LPH, KWY Dated: January 16, 2017 Received: January 18, 2017
Dear Dr. Peoples:
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 Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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)
Device Name
Revision Femoral Stem
Indications for Use (Describe)
Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ----------------------------------------------- |
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Type of Use (Select one or both, as applicable)
3
Summarv of Safety and Effectiveness
Date: February 06, 2017
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy
U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant SPeoples VMD @ gmail.com PEOPLE&ASSOCIATED CONSULTING, LLC 5010 LODGE POLE LANE FORT WAYNE INDIANA, 46814 USA Phone: 260-645-0327 FAX: +39 0432945512
| Product | Common name | Product Code | Regulation and Classification Name |
|---|---|---|---|
| Revision Femoral | |||
| Stem | Femoral Hip | ||
| Prosthesis | LZO | Hip joint metal/ceramic/polymer semi- | |
| constrained cemented or nonporous | |||
| uncemented prosthesis per 21 CFR | |||
| 888.3353 | |||
| LPH | Hip joint metal/polymer/metal semi- | ||
| constrained porous-coated uncemented | |||
| prosthesis per 21 CFR 888.3358 | |||
| KWY | Hip joint femoral (hemi-hip) | ||
| metal/polymer cemented or uncemented | |||
| prosthesis per 21 CFR 888.3390 |
Description:
The Revision Femoral Stem consists of a femoral stem and a modular neck, assembled together through a taper coupling stabilized by means of a safety screw. When used in total hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with modular femoral heads and compatible acetabular cups. When used in partial hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with a Lock Bipolar Head.
The stem is made of Ti6Al4V (ASTM F1472 – ISO 5832-3). The stem is straight, with a tapered profile, round finned section and a rounded tip to facilitate insertion. The external surface of the stem features a macro-roughened finishing obtained by sandblasting. Diameters ranging from 14 to 26 mm, with increases of 1 mm, for a total of 13 diameters are available. Two lengths (140 or 200 mm) for each diameter of the stem are available.
The neck is made of Ti6A14V (ASTM F1472 – ISO 5832-3). The same material is also used for the safety screw, which also has a small pin made of UHMWPE (ISO 5834-2,
Traditional 510(k) - Revision Femoral Stem February 06, 2017
Section 5 - Page 20 of 578
4
ASTM F648) to help prevent loosening of the safety screw. Two (2) versions of the neck are available , one with a CCD angle of 131° and another with a CCD angle of 135°. Both the neck versions are available in 7 different heights. Distally, the external surface of the neck component features a macro-roughened finishing obtained by sandblasting; proximally, the surface of the neck component is polished to reduce the chance of polyethylene wear particles if the neck accidentally rubs against the polyethylene of the acetabular component.
Indication For Use:
Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
Predicate Devices:
Revision Femoral Stem cleared via K151739-Limacorporate S.p.A.
Comparable Features to Predicate Device(s):
The Revision Femoral Stem components share the same materials, intended use and design features as those of the predicate devices. Non-clinical testing demonstrates that the subject components perform at least as well as the cited predicate.
Non-Clinical Testing:
Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:
- Fatigue testing (ISO 7206-4); -
- Fatigue testing (ISO 7206-6); -
- -Fretting evaluation:
- Analysis of disassembly torque of safety screw; -
- -Range of motion (ISO 21535).
LAL testing has been performed to establish that the subject device meet the specified 20EU/device limit.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of Revision Femoral Stem to the predicate device.