(90 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of the shoulder stem, with no mention of AI or ML.
Yes
The device is an implant for total or hemi-shoulder replacement, which is a treatment for various debilitating shoulder conditions, thus providing therapeutic benefit.
No
The device description clearly states that the "SMR Revision Stems are indicated for the treatment of fractures or revision of a failed primary component in total or hemi-shoulder replacement." This indicates a therapeutic or reconstructive purpose, not a diagnostic one.
No
The device description clearly describes physical components (stems made from Ti6Al4V) and their mechanical properties and testing, indicating it is a hardware medical device.
Based on the provided information, 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 SMR Revision Stems are described as implants made of Ti6Al4V, intended for surgical implantation in the shoulder joint. They are physical components used to replace or revise parts of the shoulder.
- Intended Use: The intended use is for the treatment of fractures or revision of failed primary components in total or hemi-shoulder replacement. This is a surgical procedure, not a diagnostic test performed on a sample.
The information clearly indicates that this is a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The SMR Revision Stems are indicated for the treatment of fractures or revision of a failed primary component in total or hemi-shoulder replacement.
The components are intended for use in cemented applications according to their labeled indication.
Total or hemi-shoulder replacement 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; .
- Revision of a failed primary component. .
Product codes (comma separated list FDA assigned to the subject device)
HSD, KWS
Device Description
The SMR Revision Stems are made from Ti6Al4V (ISO 5832-3 / ASTM F1472). They are available in two versions: cemented and uncemented.
SMR Revision cemented stems are characterized by a cylindrical shape in the distal region while the proximal part is tapered and fluted. The whole surface of the stem is polished.
SMR Revision uncemented stems are characterized by a cylindrical shape in the distal region while the proximal part is tapered and finned. The whole surface of the stem is sand-blasted.
Both the stems are provided with a male taper for the coupling with the humeral bodies and a safety screw is used to help initially seat the body on the stem taper. SMR Revision Stems can be used for anatomical (when coupled with trauma and election humeral bodies, cleared via K100858 and K101263) shoulder replacements.
SMR Revision cemented stems are intended to be used with bone cement: SMR Revision uncemented stems are intended for press-fit applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint / Humeral head
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)
The SMR systems has undergone fatigue testing to demonstrate both the strength of the humeral stem and the post-fatigue strength of the modular connections. 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 device's ability to perform under expected clinical conditions.
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.
K100858, K101263, K984541, K030941
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
§ 888.3660 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
JUL 28 2011
Summary of Safety and Effectiveness
111212
Date: April 12, 2011
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
| Product | Product Code | Regulation and Classification Name |
|---|---|---|
| SMR Revision Stems | HSD | Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis per 21 CFR 888.3690 |
| SMR Revision Stems | KWS | Shoulder joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3660 |
Description:
The SMR Revision Stems are made from Ti6Al4V (ISO 5832-3 / ASTM F1472). They are available in two versions: cemented and uncemented.
SMR Revision cemented stems are characterized by a cylindrical shape in the distal region while the proximal part is tapered and fluted. The whole surface of the stem is polished.
SMR Revision uncemented stems are characterized by a cylindrical shape in the distal region while the proximal part is tapered and finned. The whole surface of the stem is sand-blasted.
Both the stems are provided with a male taper for the coupling with the humeral bodies and a safety screw is used to help initially seat the body on the stem taper. SMR Revision Stems can be used for anatomical (when coupled with trauma and election humeral bodies, cleared via K100858 and K101263) shoulder replacements.
SMR Revision cemented stems are intended to be used with bone cement: SMR Revision uncemented stems are intended for press-fit applications.
Intended Use: The SMR Revision Stems are indicated for the treatment of fractures or revision of a failed primary component in total or hemi-shoulder replacement. Total or hemi-shoulder replacement 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; .
Traditional 510(k) - SMR Revision Stems April 12, 2011
Company Confidential Section 5 - Page 17 of 228
1
- . Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods
- Cuff tear arthropaty: .
- . Revision of a failed primary component.
Predicate Devices:
- SMR Shoulder System (Lima-Lto, K100858) and SMR Uncemented Shoulder . System (Lima-Lto, K101263);
- Global FX humeral stem (DePuy, K984541); ;
- Aequalis Reversed Shoulder Prosthesis (Tornier, K030941); .
11/212
Comparable Features to Predicate Device(s):
The SMR Revision stems are similar to the predicate devices in terms of intended use, indications, design and materials. The SMR Revision stems and the predicates are all intended for partial or total primary shoulder joint replacement. The SMR Revision stems are intended for cemented or uncemented use, depending on the design, as are the predicate humeral stems.
The SMR Revision stems are provided with the same taper connection to join the SMR system humeral stems and the humeral bodies components cleared via K100858 and K101263. The surface finishing and geometrical features are the SMR systems primary stems. Revision stems length and diameters are similar to those of DePuy Global FX and Tornier Aequalis shoulder systems.
The SMR Revision stems are manufactured from the same or similar materials as the predicate devices. The SMR humeral stems are manufactured from Ti6A14V while the Global FX and Aequalis stems are manufactured from cast CoCrMo.
Non-Clinical Testing:
The SMR systems has undergone fatigue testing to demonstrate both the strength of the humeral stem and the post-fatigue strength of the modular connections. 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 device's ability to perform under expected clinical conditions.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Shoulder System to the predicate device(s).
Traditional 510(k) - SMR Revision Stems April 12, 2011
Company Confidential Section 5 - Page 18 of 228
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Limacorporate S.p.A % Ms. Cheryl Hastings Principal Consultant P.O. Box 696 Winona Lake, Indiana 46590-696
JUL 28 2011
Re: K111212
Trade/Device Name: SMR Revision Stems 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: April 12, 2011 Received: April 29, 2011
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 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 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.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): Unknown
Device Name: SMR Revision Stems
Indications for Use:
SMR Revision Stems Indications for Use
111212
The SMR Revision Stems are indicated for the treatment of fractures or revision of a failed primary component in total or hemi-shoulder replacement.
The components are intended for use in cemented applications according to their labeled indication.
Total or hemi-shoulder replacement 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; .
- Revision of a failed primary component. .
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)
Mark A. Milburn
Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K 111212
Page 1 of 1
Traditional 510(k) - SMR Revision Stems April 12, 2011
Company Confidential Section 4 - Page 15 of 228