(46 days)
No
The document describes a medical device (humeral heads for shoulder arthroplasty) and its compatibility with other components. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The focus is on mechanical compatibility and material properties.
Yes
The device is described as an implant used in total or hemi-shoulder joint arthroplasty to treat various conditions like degenerative joint disease, inflammatory degenerative joint disease, and acute fractures of the humeral head, which are all therapeutic interventions designed to alleviate pain and restore joint function.
No
Explanation: The device is an orthopedic implant (humeral heads for shoulder arthroplasty) intended for treatment, not for diagnosing medical conditions.
No
The device description clearly indicates that the device is a physical implant (humeral heads) used in shoulder joint arthroplasty, not a software product.
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 replacing parts of the shoulder joint. This is a medical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details physical components like humeral heads, stems, bodies, and glenoid components, which are all parts of a surgical implant.
- Lack of Diagnostic Language: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Clinical Context: The indications for use are related to treating conditions like osteoarthritis, rheumatoid arthritis, fractures, and cuff tear arthropathy through surgical intervention.
Therefore, this device falls under the category of a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The glenoid is intended for cemented use only. Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from disability due to:
- . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- . Inflammatory degenerative joint disease such as rheumatoid arthritis;
- . Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
- . Cuff tear arthropathy.
Product codes (comma separated list FDA assigned to the subject device)
KWS, HSD
Device Description
The SMR CTA Humcral Heads (cleared via 510(k): K110847) are intended for use with a humcral body - humeral stem assembly in total or hemi-shoulder joint arthroplasty. The CTA heads are coupled with the humeral bodies by means of an adaptor taper. When used in total shoulder replacement, the SMR CTA Humeral Heads are coupled with glenoid components.
The SMR CTA Humeral Heads were cleared in K110847 for use with the humeral stems, humeral bodics, adaptor tapers and glenoid components cleared in K100858, K101263 and K113254.
This submission is to modify the labeling for the SMR CTA Humeral Heads to add the SMR Reverse Humeral Bodies, cleared via K110598, as additional compatible components. An adaptor for the reverse humeral body is being added to allow coupling between the SMR CTA Humeral Heads and the SMR Reverse humeral body. When used with the CTA Humeral Heads, the SMR Reverse Humeral Bodies are intended for anatomic shoulder replacement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
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 Testing: A print review was conducted to compare the taper dimensions and tolerances of the adaptor used for coupling the SMR CTA Humeral Heads to the SMR Reverse Humcral Bodies with the taper coupling for the SMR reverse humeral bodies and liners cleared via K110598 and with the taper coupling for the SMR CTA Humeral Heads and adaptors cleared via K110847. These comparisons indicate that the adaptor tapers for the coupling of the reverse humeral bodies and the CTA heads is equivalent in dimensions and tolerances to the predicates. A review of previously conducted fretting / corrosion testing also indicates that the SMR CTA Humeral Head / SMR Reverse Humeral Body adaptor does not introduce new risks of fretting or corrosion.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SMR CTA Humeral Heads with modified labeling 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.
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
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
K131112 Page 1 of 2
JUN 0 7 2013
510(k) Summary
Date: May 15, 2013
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Cheryl Hastings Principal Consultant Phone: 574-527-4220 FAX: +39 0432945512
| Product | Common
Name | Product
Code | Regulation and Classification Name |
|--------------------------|--------------------------------------------|-----------------|----------------------------------------------------------------------------------------------|
| SMR CTA
Humeral Heads | Total or
Hemi
Shoulder
Prosthesis | KWS | Shoulder joint metal/polymer semi-constrained
cemented prosthesis per 21 CFR 888.3660 |
| | | HSD | Shoulder joint humeral (hemi-shoulder) metallic
uncemented prosthesis per 21 CFR 888.3690 |
Description:
The SMR CTA Humcral Heads (cleared via 510(k): K110847) are intended for use with a humcral body - humeral stem assembly in total or hemi-shoulder joint arthroplasty. The CTA heads are coupled with the humeral bodies by means of an adaptor taper. When used in total shoulder replacement, the SMR CTA Humeral Heads are coupled with glenoid components.
The SMR CTA Humeral Heads were cleared in K110847 for use with the humeral stems, humeral bodics, adaptor tapers and glenoid components cleared in K100858, K101263 and K113254.
This submission is to modify the labeling for the SMR CTA Humeral Heads to add the SMR Reverse Humeral Bodies, cleared via K110598, as additional compatible components. An adaptor for the reverse humeral body is being added to allow coupling between the SMR CTA Humeral Heads and the SMR Reverse humeral body. When used with the CTA Humeral Heads, the SMR Reverse Humeral Bodies are intended for anatomic shoulder replacement.
Intended Use / Indications:
The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The glenoid is intended for cemented use only. Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from disability due to:
- . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- . Inflammatory degenerative joint discase such as rheumatoid arthritis;
- . Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
- . Cuff tear arthropathy.
1
Predicate Device:
Limacorporate SMR CTA Humeral Heads (K110847) Limacorporate SMR Reverse Shoulder System (K110598)
Summary of Technologies/Substantial Equivalence:
Based on similarities in indications, intended use, design, materials, surface finishing, method of manufacture and a print review to compare taper dimensions and tolerances, Limacorporate believes that the SMR CTA Humeral Heads with modified labeling to include the SMR Reverse Humeral Bodies as compatible components are substantially equivalent to the SMR CTA Humeral Heads cleared in K110847.
Non-Clinical Testing:
A print review was conducted to compare the taper dimensions and tolerances of the adaptor used for coupling the SMR CTA Humeral Heads to the SMR Reverse Humcral Bodies with the taper coupling for the SMR reverse humeral bodies and liners cleared via K110598 and with the taper coupling for the SMR CTA Humeral Heads and adaptors cleared via K110847. These comparisons indicate that the adaptor tapers for the coupling of the reverse humeral bodies and the CTA heads is equivalent in dimensions and tolerances to the predicates. A review of previously conducted fretting / corrosion testing also indicates that the SMR CTA Humeral Head / SMR Reverse Humeral Body adaptor does not introduce new risks of fretting or corrosion.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the SMR CTA Humeral Heads with modified labeling to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2013
Limacorporate S.p.A. % Ms. Cheryl Hastings Principal Consultant P.O. Box 696 Winona Lake. Indiana 46590-0696
Re: K131112
Trade/Device Name: SMR CTA Humeral Heads Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: May 3, 2013 Received: May 10, 2013
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-Eosmetic-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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Cheryl Hastings
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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.
For
Sincerely yours.
Erin.Keith
Mark N. Melkerson Director Division of Orthopedic Devices_ Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K131112 510(k) Number (if known):
SMR CTA Humeral Heads Indications for Use
The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The glenoid is intended for cemented use only. Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from disability due to:
- . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- . Inflammatory degenerative joint disease such as rheumatoid arthritis;
- . Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
- Cuff tear arthropathy. .
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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page I of 1
Special 510(k) - Device Modification: SMR CTA Humeral Heads March 05, 2013
Page 6 of 144