(477 days)
Not Found
No
The summary describes a mechanical implant (femoral stem) and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are mechanical tests.
Yes.
The device is indicated for total hip arthroplasty to reduce or relieve pain and improve hip function, which are therapeutic benefits.
No
Explanation: The device is a femoral stem system for total hip arthroplasty, and its intended use is for actual surgical implantation, not for diagnosing conditions or diseases.
No
The device description clearly states it is a physical implant (femoral stem, head, and cup) made of materials like Ti6Al4V and CoCrMo, with a hydroxyapatite coating. This is a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip arthroplasty, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as a femoral stem, femoral head, and acetabular cup, which are physical implants used in surgery.
- No mention of in vitro testing: The text does not mention any testing of samples (blood, tissue, etc.) outside of the body for diagnostic purposes.
- Performance Studies: The performance studies described are mechanical testing (fatigue, pull-off, range of motion) and characterization of the coating, which are relevant to the physical performance and safety of an implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to replace a joint.
N/A
Intended Use / Indications for Use
The H-Max S stems are indicated for use in total hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stems are intended for use with Co-Cr-Mo femoral heads and Limacorporate standard and protruded cemented cups. The standard and protruded cemented cups are intended for cemented use only.
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 such as osteoarthritis, avascular necrosis and hip dysplasia;
- · rheumatoid arthritis;
- · treatment of femoral head and neck fractures;
- · revisions in cases of good remaining femoral bone stock.
Product codes (comma separated list FDA assigned to the subject device)
MEH, JDI
Device Description
The H-MAX S femoral system consists of the H-MAX S femoral stem, a femoral head and an acetabular cup. The H-Max S Stems are intended for use with CoCrMo femoral heads and Limacorporate Cemented cups.
The H-MAX S femoral stem is a monolithic cementless stem made from Ti6Al4V (ISO 5832-3, ASTM F1472). The external surface has a macro-roughened surface. A layer of hydroxyapatite is applied along the length of the stem. The H-MAX S stem is manufactured in 11 sizes for each of two configurations (standard and lateralizing) that vary in the CCD angle.
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 H-MAX S femoral hip system has undergone fatigue testing to demonstrate the strength of the femoral stem and the femoral neck. Pull-off testing to demonstrate the strength of the taper connection between the femoral stem and the modular CoCrMo heads has also been completed. A simulation of the Range of Motion has been performed to ensure the device design does not overly limit range of motion.
All mechanical testing was done on worst case components or constructs. Where possible, standard test methods were used to allow comparison to testing of the predicate devices. The testing results demonstrated the system's ability to perform under expected clinical conditions.
The Hydroxyapatite coating has been characterized according to the FDA guidance documents.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the H-MAX S femoral hip system to the predicate devices.
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
Summary of Safety and Effectiveness
Date: September 5, 2012
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person:
9 2012 NOV
Cheryl Hastings Principal Consultant Phone: 574-527-4220
| Product | Product Code | Regulation and Classification Name |
|---|---|---|
| H-Max S femoral hip system | MEH | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per 21 CFR 888.3353 |
| JDI | Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350 |
Description:
The H-MAX S femoral system consists of the H-MAX S femoral stem, a femoral head and an acetabular cup. The H-Max S Stems are intended for use with CoCrMo femoral heads and Limacorporate Cemented cups.
The H-MAX S femoral stem is a monolithic cementless stem made from Ti6Al4V (ISO 5832-3, ASTM F1472). The external surface has a macro-roughened surface. A layer of hydroxyapatite is applied along the length of the stem. The H-MAX S stem is manufactured in 11 sizes for each of two configurations (standard and lateralizing) that vary in the CCD angle.
Intended Use:
The H-Max S stems are indicated for use in total hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stems are intended for use with Co-Cr-Mo femoral heads and Limacorporate standard and protruded cemented cups. The standard and protruded cemented cups are intended for cemented use only.
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 such as osteoarthritis, avascular necrosis and hip dysplasia;
- · rheumatoid arthritis;
- · treatment of femoral head and neck fractures;
- · revisions in cases of good remaining femoral bone stock.
Traditional 510(k) - H-MAX S femoral hip system
1
K112091 Page 2 of 2
Predicate Devices:
Corail AMT Femoral stem (Depuy, K042992)
Comparable Features to Predicate Device(s): the H-MAX S femoral hip system is similar to the predicate devices in terms of intended use, indications, design and materials.
The H-Max S stem and the Corail AMT stem are both indicated for use in total hip arthroplasty for press-fit (uncemented) use. Like the Corail AMT hip prosthesis, the H-MAX S femoral stem is a monolithic stem with a wide medial curvature and an A-P profile characterized by the "V" shape in the proximal part. Both prostheses are characterized by a 12/14 neck-head taper and the surface has a layer of Hydroxyapatite. The components of the H-MAX S femoral hip system are manufactured from the same materials as the predicate devices.
Non-Clinical Testing: The H-MAX S femoral hip system has undergone fatigue testing to demonstrate the strength of the femoral stem and the femoral neck. Pull-off testing to demonstrate the strength of the taper connection between the femoral stem and the modular CoCrMo heads has also been completed. A simulation of the Range of Motion has been performed to ensure the device design does not overly limit range of motion.
All mechanical testing was done on worst case components or constructs. Where possible, standard test methods were used to allow comparison to testing of the predicate devices. The testing results demonstrated the system's ability to perform under expected clinical conditions.
The Hydroxyapatite coating has been characterized according to the FDA guidance documents.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the H-MAX S femoral hip system to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person. The symbol is made up of three curved lines that form the shape of two figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 9, 2012
Limacorporate SPA % Hastings Regulatory Consulting, LLC Ms. Cheryl Hastings Principal Consultant P.O. Box 696 Winona Lake, Indiana 46590-696
Re: K112091
Trade/Device Name: H-MAX S femoral hip system 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: MEH, JDI Dated: September 05, 2012
Received: October 01, 2012
Dear Ms. Hastings:
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
3
Page 2 - Ms. Cheryl Hastings
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 (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K112091 --
Device Name: H-MAX S femoral hip system
Indications for Use:
H-MAX S femoral hip system Indications for Use
The H-Max S stems are indicated for use in total hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stems are intended for use with Co-Cr-Mo femoral heads and Limacorporate standard and protruded cemented cups. The standard and protruded cemented cups are intended for cemented use only.
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 such as osteoarthritis, avascular necrosis and hip dysplasia;
- · rheumatoid arthritis;
- · treatment of femoral head and neck fractures;
- · revisions in cases of good remaining femoral bone stock. ·
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Surgica' Orthopedic, and Restorative Devices
510(k) Number K112091
Page 1 of 1
Traditional 510(k) – H-MAX S femoral hip system September 5, 2012
Section 4 - Page 15 of 354