(21 days)
No
The 510(k) summary describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or AI/ML capabilities. The submission is focused on adding compatible components and demonstrating substantial equivalence through mechanical testing and dimensional comparisons.
Yes
The device is a total shoulder replacement system, which by definition is used to treat a medical condition (severe arthropathy and rotator cuff deficiency) within the body and is implanted to restore function, making it a therapeutic device.
No
Explanation: The device is a reverse shoulder replacement system, which is a prosthetic implant used for total shoulder replacement, not for diagnosing medical conditions.
No
The device description explicitly details physical components like humeral stems, reverse humeral bodies, liners, glenospheres, connectors, and screws, which are hardware implants for surgical use.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like stems, bodies, liners, and screws, which are typical of orthopedic implants.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing information for diagnosis.
- Performance Studies: The performance studies focus on mechanical compatibility and equivalence of components, not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The SMR Reverse Shoulder System humeral bodies, cemented non-finned humeral stems and cemented revision stems are intended for cemented use. The SMR Reverse Shoulder System humeral bodies, finned humeral stems and uncemented revision stems are intended for cementless use. The SMR Reverse Shoulder System metal-backed glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation.
Product codes
PHX, KWS
Device Description
The SMR Reverse Shoulder System (cleared via 510(k): K110598) consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenosphere and a connector with screw. Bone screws are used for the fixation of the metal-back glenoid to the scapula. Humeral stems and reverse humeral bodies are provided for both cementless fixation. The SMR Reverse Shoulder System metal back glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation.
This submission is to add the SMR Revision Stems, cleared in K111212, as compatible humeral stem components of the SMR Reverse Shoulder System.
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
Non-Clinical Testing: A print review was conducted to compare the taper dimensions and tolerances of the SMR Revision Stems to the taper dimensions and tolerances of the SMR humeral stems cleared for use with the SMR Reverse Shoulder System in K110598. This comparison indicated that the SMR Revision Stem tapers were substantially equivalent to the SMR Humeral Stem tapers.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Reverse Shoulder System with modified labeling to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Limacorporate S.p.A. % Ms. Cheryl Hastings Hastings regulatory LLC P.O. Box 696 Winona Lake, Indiana 46590-696
Re: K113523
Trade/Device Name: SMR Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: November 22, 2011 Received: November 29, 2011
Dear Ms. Hastings:
This letter corrects our substantially equivalent letter of December 20, 2011.
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
1
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 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/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 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 yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known): K113523
SMR Reverse Shoulder System Indications for Use
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The SMR Reverse Shoulder System humeral bodies, cemented non-finned humeral stems and cemented revision stems are intended for cemented use. The SMR Reverse Shoulder System humeral bodies, finned humeral stems and uncemented revision stems are intended for cementless use. The SMR Reverse Shoulder System metal-backed glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation.
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)
Es Mark. Milhenson
(Division Sign-C (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113523
Special 510(k) - Device Modification: SMR Reverse Shoulder System November 21, 2011
Company Confidential Page 7
3
KI13523
510(k) Summary
Date: November 21, 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 Reverse Shoulder | ||
| System | KWS | Shoulder joint metal/polymer semi-constrained |
| cemented prosthesis per 21 CFR 888.3660 |
Description:
11
The SMR Reverse Shoulder System (cleared via 510(k): K110598) consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenosphere and a connector with screw. Bone screws are used for the fixation of the metal-back glenoid to the scapula. Humeral stems and reverse humeral bodies are provided for both cementless fixation. The SMR Reverse Shoulder System metal back glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation.
This submission is to add the SMR Revision Stems, cleared in K111212, as compatible humeral stem components of the SMR Reverse Shoulder System.
Intended Use / Indications:
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The SMR Reverse Shoulder System humeral bodies, cemented non-finned humeral stems and cemented revision stems are intended for cemented use. The SMR Reverse Shoulder System humeral bodies, finned humeral stems and uncemented revision stems are intended for cementless use. The SMR Reverse Shoulder System metal-backed glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation.
Special 510(k) - Device Modification: SMR Reverse Shoulder System November 21, 2011
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KII3523
Predicate Device:
Limacorporate SMR Reverse Shoulder System (K110598)
Summary of Technologies/Substantial Equivalence:
Based on similarities in indications, intended use, design, materials, method of manufacture and a print review to compare taper dimensions and tolerances, Limacorporate believes that the SMR Reverse Shoulder with modified labeling to include the SMR Revision Stems as compatible components is substantially equivalent to the SMR Reverse Shoulder System cleared in K110598.
Non-Clinical Testing:
A print review was conducted to compare the taper dimensions and tolerances of the SMR Revision Stems to the taper dimensions and tolerances of the SMR humeral stems cleared for use with the SMR Reverse Shoulder System in K110598. This comparison indicated that the SMR Revision Stem tapers were substantially equivalent to the SMR Humeral Stem tapers.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Reverse Shoulder System with modified labeling to the predicate device.
Special 510(k) - Device Modification: SMR Reverse Shoulder System November 21, 2011
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