(265 days)
No
The document describes a mechanical hip implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is a femoral stem used in hip arthroplasty, which is intended for the "reduction or relief of pain and/or improved hip function." These are therapeutic outcomes.
No
Explanation: The device described is a monolithic cementless femoral stem used in hip arthroplasty to replace damaged hip joints. It is a prosthetic implant, not a tool or system used to diagnose a medical condition. Its intended use is treatment (reduction/relief of pain and improved hip function), not diagnosis.
No
The device description clearly states it is a "monolithic collarless stem" made of "Ti6Al4V," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "partial or total hip arthroplasty" to "reduction or relief of pain and/or improved hip function." This describes a surgical implant used to treat a physical condition.
- Device Description: The description details a "femoral stem" made of specific materials and designed for surgical implantation in the hip.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens derived from the human body. IVDs are used for testing samples like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening.
This device is a surgical implant used in hip replacement procedures, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Monolithic cementless stems are indicated for use in partial or total hip arthroplasty and they are intended for press-fit (uncemented) use.
When used in total hip arthroplasty, monolithic cementless stems are with modular heads and compatible acetabular cups.
When used in partial hip arthroplasty, they are intended for use with bipolar heads.
Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
· non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia;
• rheumatoid arthritis;
· revisions in cases of good remaining femoral bone stock;
· treatment of femoral head and neck fractures.
Product codes
LZO, LWJ, KWY
Device Description
The C2 femoral stem is intended for partial or total hip arthroplasty in cementless use in primary or revision cases. It is a monolithic collarless stem available in 14 sizes for both standard and lateralized versions and 8 sizes in revision version.
When used in total hip arthroplasty C2 femoral stems are coupled to previously cleared Limacorporate components:
- . Biolox Delta femoral heads or Limacorporate Femoral Heads articulating with Limacorporate Cemented Cups or
- Biolox Delta heads or Limacorporate Femoral Heads articulating with Delta TT ● Acetabular System.
When used in partial hip arthroplasty the C2 femoral stem is coupled to previously cleared Limacorporate Lock Bipolar Heads.
The C2 femoral stem is made of Ti6Al4V conforming to the specifications ASTM F1472 - ISO 5832-3. The stem is characterized by a 12/14 conical taper to be coupled to Limacorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads. In addition necks are mirror-polished to reduce abrasion of the UHMWPE cups in case of abnormal contact. The stem has a rectangular section and is characterized by a "V" shaped A-P profile to improve adaptability to the most common bone morphologies and to facilitate insertion of the stem in the canal.
The C2 femoral stem is suitable for both first implant and revision versions. The first implant versions are available in standard and lateralized versions with different CCD angles (131° and 134°), offsets and stem lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature patients
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 Testing:
The C2 femoral stem was tested for fatigue resistance. The following tests were performed to demonstrate substantial equivalency of the C2 femoral stem to predicate devices:
- . Fatigue Test according to ISO 7206-4;
- Fatigue Test according to ISO 7206-6. .
A simulation of Range of Motion has been performed to ensure the device design does not overly limit range of motion.
All mechanical tests were performed on worst case components or constructs. The tests results demonstrated the device's ability to perform under expected clinical conditions. Endotoxin testing has been performed on Limacorporate products.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the C2 femoral stem to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
H-MAX S stem (Limacorporate, K112091 K150855 K160011), Alloclassic Zweymüller Stems (Zimmer, K962101, K030373, K033664), SL-PLUS stem (Smith&Nephew, K072852, K120211, K143096)
Reference Device(s)
Modulus stem (Limacorporate, K112158), Tibial winged broach (Limacorporate, K141934), H-MAX broach (Limacorporate, K112091), Stem Impactor (Limacorporate, K100858), Manual Impactor (Limacorporate, K151739)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2017
Limacorporate S.p.A. % Stephen Peoples Principal Consultant People & Associated Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, IN 46814 US
Re: K170473
Trade/Device Name: C2 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, LWJ, KWY Dated: September 29, 2017 Received: October 3, 2017
Dear Stephen 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
C2 femoral stem
Indications for Use (Describe)
Monolithic cementless stems are indicated for use in partial or total hip arthroplasty and they are intended for press-fit (uncemented) use.
When used in total hip arthroplasty, monolithic cementless stems are with modular heads and compatible acetabular cups.
When used in partial hip arthroplasty, they are intended for use with bipolar heads.
Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
· non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia;
• rheumatoid arthritis;
· revisions in cases of good remaining femoral bone stock;
· treatment of femoral head and neck fractures.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Summary of Safety and Effectiveness
Date: November 08, 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 SPeoplesVMD@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 |
|--------------------|---------------------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------|
| C2 femoral
stem | Total or
Hemi
Hip
Prosthesis | LZO | Hip joint, Semi-Constrained,
Metal/Ceramic/Polymer, Cemented Or
Non-Porous, Uncemented prosthesis, per
21CFR 888.3353 |
| | | LWJ | Hip joint, Semi-Constrained,
Metal/Polymer, Uncemented prosthesis,
per 21CFR 888.3360 |
| | | KWY | Hip joint, Hemi-, Femoral, Metal/Polymer,
Cemented Or Uncemented prosthesis, per
21CFR 888.3390 |
Description:
The C2 femoral stem is intended for partial or total hip arthroplasty in cementless use in primary or revision cases. It is a monolithic collarless stem available in 14 sizes for both standard and lateralized versions and 8 sizes in revision version.
When used in total hip arthroplasty C2 femoral stems are coupled to previously cleared Limacorporate components:
- . Biolox Delta femoral heads or Limacorporate Femoral Heads articulating with Limacorporate Cemented Cups or
- Biolox Delta heads or Limacorporate Femoral Heads articulating with Delta TT ● Acetabular System.
When used in partial hip arthroplasty the C2 femoral stem is coupled to previously cleared Limacorporate Lock Bipolar Heads.
The C2 femoral stem is made of Ti6Al4V conforming to the specifications ASTM F1472 - ISO 5832-3. The stem is characterized by a 12/14 conical taper to be coupled to Limacorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads. In
Traditional 510(k) – C2 femoral stem November 08, 2017
4
addition necks are mirror-polished to reduce abrasion of the UHMWPE cups in case of abnormal contact. The stem has a rectangular section and is characterized by a "V" shaped A-P profile to improve adaptability to the most common bone morphologies and to facilitate insertion of the stem in the canal.
The C2 femoral stem is suitable for both first implant and revision versions. The first implant versions are available in standard and lateralized versions with different CCD angles (131° and 134°), offsets and stem lengths.
Intended Use:
Monolithic cementless stems are indicated for use in partial or total hip arthroplasty and they are intended for press-fit (uncemented) use.
When used in total hip arthroplasty, monolithic cementless stems are intended for use with modular heads and compatible acetabular cups.
When used in partial hip arthroplasty, they are intended for use with bipolar heads.
Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
· non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia;
- rheumatoid arthritis;
- · revisions in cases of good remaining femoral bone stock.
- · treatment of femoral head and neck fractures.
Predicate Devices:
- H-MAX S stem (Limacorporate, K112091 K150855 K160011). ●
- Alloclassic Zweymüller Stems (Zimmer, K962101, K030373, K033664); ●
- SL-PLUS stem (Smith&Nephew, K072852, K120211, K143096);
Reference Devices:
- Modulus stem (Limacorporate, K112158). ●
- Tibial winged broach (Limacorporate, K141934). o
- H-MAX broach (Limacorporate, K112091).
- Stem Impactor (Limacorporate, K100858). ●
- Manual Impactor (Limacorporate, K151739).
Comparable Features to Predicate Device(s):
The C2 stems are similar to the predicate devices in terms of intended use, indications, design and materials. The C2 stems can be used in total hip arthroplasty as all predicates and they can be used also in partial hip arthroplasty in the same way of the previously cleared H-MAX S stem. All stems are intended for cementless use.
The C2 femoral stems have a design which is similar to predicates. Like predicates, the
Traditional 510(k) – C2 femoral stem November 08, 2017
5
subject device is available for first implant (in standard and lateralized versions, with different CCD angles, offsets and sizes) and for revision implant (in different sizes). The C2 stems are manufactured from the same materials as the H-MAX S stem.
Non-Clinical Testing:
The C2 femoral stem was tested for fatigue resistance. The following tests were performed to demonstrate substantial equivalency of the C2 femoral stem to predicate devices:
- . Fatigue Test according to ISO 7206-4;
- Fatigue Test according to ISO 7206-6. .
A simulation of Range of Motion has been performed to ensure the device design does not overly limit range of motion.
All mechanical tests were performed on worst case components or constructs. The tests results demonstrated the device's ability to perform under expected clinical conditions. Endotoxin testing has been performed on Limacorporate products.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the C2 femoral stem to the predicate devices.
Traditional 510(k) – C2 femoral stem November 08, 2017