(169 days)
No
The document describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
This device is a total shoulder replacement system, which by its nature is designed to treat severe arthropathy and restore function to a joint, making it a therapeutic device.
No
Explanation: The SMR Reverse Shoulder System is described as a device for total shoulder replacement, consisting of implants like humeral stems, glenoids, and glenospheres. Its intended use is to replace a joint, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines multiple physical components made of various materials (Ti6Al4V, UHMWPE, CoCrMo alloy) intended for surgical implantation. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SMR Reverse Shoulder System is for "primary, fracture or revision total shoulder replacement." This is a surgical implant used in vivo (within the body) to replace a joint.
- Device Description: The description details the physical components of a shoulder prosthesis (stems, bodies, liners, glenoids, glenospheres, connectors, screws). These are all physical devices implanted during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SMR Reverse Shoulder System does not perform any such function.
Therefore, the SMR Reverse Shoulder System is a surgical implant, not an In Vitro Diagnostic device.
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 components are intended for use in cemented and uncemented applications, as specified in the following table:
| COMPONENT | USE | |
|---|---|---|
| Cemented | Uncemented | |
| Cemented stems | X | |
| Cementless Finned stems | X | |
| Reverse Humeral Bodies | X | X |
| Reverse Liners | X | X |
| Glenospheres | X | |
| Connectors | X | |
| Metal Back Glenoid | X | |
| Bone Screws | X |
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS
Device Description
The SMR Reverse Shoulder System consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenoid, a glenosphere and a connector with screw. Bone screws are used for the fixation of the metal-back glenoid to the scapula. Humeral stems are provided for both cemented (cleared via 510(k): K100858) and cementless (cleared via 510(k): K101263) fixation as well as reverse humeral bodies (object of this submission). 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. Two designs of humeral stems are available: the first one (cleared via 510(k): K100858) is intended for cemented use only while the second one (cleared via 510(k): K101263) is intended for uncemented use. The stems are provided with a male Morse taper to allow coupling with the reverse humeral bodies. All reverse humeral bodies for SMR Reverse Shoulder Systems are made from Ti6Al4V (ASTM F1472 - ISO 5832-3). They are intended to be coupled by means of a Morse taper with the humeral stem; further stabilization is achieved with a screw that joins the humeral body to the stem. SMR reverse humeral bodies have a fixed cervico-diaphyseal angle of 150° to provide the correct varus-valgus alignment of the joint. The humeral body has a female taper for coupling with the reverse liner. Two versions of the SMR reverse liners are available: standard (available in Standard and Short sizes) and finned for trauma applications (fins with holes for tuberosities reconstruction provided). Reverse liners are made from standard ultra-high molecular weight polycthylene (ASTM F648 - ISO 5834-2); they are coupled via the internal tapcr of the reverse humeral bodies. Two designs of reverse liners are available: standard and retentive (characterized by deeper spherical concavity, higher lateral rim to provide a larger articulating surface and greater congruency between the liner and the glenosphere than the standard liners). Three thicknesses are available: STD, +3mm and +6mm. As reported for standard liners, the choice of the thickness is made by the surgeon to ensure the appropriate tension and prevent laxity in the joint. Metal-backed glenoids are made from Ti6Al4V (ASTM F1472 - ISO 5832-3). The surface of the metal-backed glenoid which comes in contact with bone is coated with Ti plasma spray coating. These devices are intended to be press-fitted
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
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 Principal Consultant P.O. Box 696 Winona Lake, Indiana 46590-696
Re: K110598
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: August 5, 2011 Received: August 12, 2011
Dear Ms. Hastings:
This letter corrects our substantially equivalent letter of August 18, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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
(21 Of RT att 603) produces/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
510(k) Number (if known): Unknown K | 0598
Device Name: SMR Reverse Shoulder System
Indications for Use:
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 components are intended for use in cemented and uncemented applications, as specified in the following table:
| COMPONENT | USE | |
|---|---|---|
| Cemented | Uncemented | |
| Cemented stems | X | |
| Cementless Finned stems | X | |
| Reverse Humeral Bodies | X | X |
| Reverse Liners | X | X |
| Glenospheres | X | |
| Connectors | X | |
| Metal Back Glenoid | X | |
| Bone Screws | X |
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)
Igor M. Melkerson
(Division/Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110598
Page 1 of 1
Traditional 510(k) - SMR Reverse Shoulder System February 18, 2011
Section 4 - Page 15 of 522
3
AUG 1 8 2011
Summary of Safety and Effectiveness
Date: June 10, 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:
The SMR Reverse Shoulder System consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenoid, a glenosphere and a connector with screw. Bone screws are used for the fixation of the metal-back glenoid to the scapula. Humeral stems are provided for both cemented (cleared via 510(k): K100858) and cementless (cleared via 510(k): K101263) fixation as well as reverse humeral bodies (object of this submission). 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.
Two designs of humeral stems are available: the first one (cleared via 510(k): K100858) is intended for cemented use only while the second one (cleared via 510(k): K101263) is intended for uncemented use. The stems are provided with a male Morse taper to allow coupling with the reverse humeral bodies.
All reverse humeral bodies for SMR Reverse Shoulder Systems are made from Ti6Al4V (ASTM F1472 - ISO 5832-3). They are intended to be coupled by means of a Morse taper with the humeral stem; further stabilization is achieved with a screw that joins the humeral body to the stem. SMR reverse humeral bodies have a fixed cervico-diaphyseal angle of 150° to provide the correct varus-valgus alignment of the joint. The humeral body has a female taper for coupling with the reverse liner. Two versions of the SMR reverse liners are available: standard (available in Standard and Short sizes) and finned for trauma applications (fins with holes for tuberosities reconstruction provided).
Reverse liners are made from standard ultra-high molecular weight polycthylene (ASTM F648 - ISO 5834-2); they are coupled via the internal tapcr of the reverse humeral bodies. Two designs of reverse liners are available: standard and retentive (characterized
Traditional 510(k) -SMR Reverse Shoulder System June 10, 2011
Page 1 of 4
4
KII 0598
by deeper spherical concavity, higher lateral rim to provide a larger articulating surface and greater congruency between the liner and the glenosphere than the standard liners).
Three thicknesses are available: STD, +3mm and +6mm. As reported for standard liners, the choice of the thickness is made by the surgeon to ensure the appropriate tension and prevent laxity in the joint.
Metal-backed glenoids are made from Ti6Al4V (ASTM F1472 - ISO 5832-3). The surface of the metal-backed glenoid which comes in contact with bone is coated with Ti plasma spray coating. These devices are intended to be press-fitted into a hole drilled into the glenoid cavity during surgery; the peg surface has several wings to aid in fixation. Metal backed glenoids are available in four sizes (small-R, Small, Standard and Large).
The plate has curved surfaces to adapt to the spherical shape of the glenoid cavity. The plate is provided with holes to allow the insertion of screws to fix the device in the glenoid cavity: Small-R, Small and Standard glenoids have two holes while the Large size has four holes.
Glenospheres are made from CoCrMo alloy that conforms to ASTM F1537 - ISO 5832-12. Two different designs are available: a standard glenosphere that can be centered with respect to the glenoid component or eccentrical glenosphere to provide offset. Both designs have a spherical shape of 36mm diameter and articulate with the standard UHMWPE liners of the humeral body.
Glenospheres are intended to be coupled to the metal-back glenoid through the use of a connector manufactured of Ti6Al4V (ASTM F1472 - ISO 5832-3). It incorporates a double male taper: one side is connected to the glenosphere while the other is coupled with the glenoid component. To increase the solidity of the system, a screw is used to link the glenosphere to the glenoid component. The screw is inserted through a hole on the surface of the glenosphere, passing through the internal cavity of the connector and then screwed to the metal-backed liner. Two types of connectors are used depending on the metal backed glenoid component: Small-STD and Small-R.
Intended Use:
ﻣ ..
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 components are intended for use in cemented and uncemented applications, as specified in the following table:
Traditional 510(k) -SMR Reverse Shoulder System June 10, 2011
Page. 2 of 4
5
KII 2598
| COMPONENT | USE | |
|---|---|---|
| Cemented | Uncemented | |
| Cemented stems | X | |
| Cementless Finned stems | X | |
| Reverse Humeral Bodies | X | X |
| Reverse Liners | X | X |
| Glenospheres | X | |
| Connectors | X | |
| Metal Back Glenoid | X | |
| Bone screws | X |
Predicate Devices:
Promos Reverse Shoulder System (Plus Orthopedics, K081016); Inverse/reverse Shoulder System (Zimmer, K053274); Delta Xtend Reverse Shoulder (DePuy, K091751).
Comparable Features to Predicate Device(s):
The SMR Reverse Shoulder System is similar to the predicate devices in terms of intended use, indications, design and materials. The SMR Reverse Shoulder System and the predicates are all intended for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy.
The SMR humeral stems are intended for cemented or uncemented use, depending on the design, as are the predicate humeral stems. Reverse bodies are intended for cemented or uncemented use, they follow the indication of the humeral stems. The SMR and predicate glenoid baseplates are all intended for uncemented use only with the use of bone screws for additional fixation.
Like the Promos Modular Shoulder System, the SMR Shoulder System provides modular humeral stem and humeral body components. The Inverse/reverse and Delta Xtend Shoulder Systems are designed as a one-piece humeral stem / body component and have humeral cups to host reverse liners. All the systems are provided with reverse liners and glenospheres of similar diameters that are intended to articulate together. In all the systems the glenospheres are fixed to the glenoid bone through the use of a glenoid baseplate (also called metal back glenoid).
The components of the SMR Shoulder System are manufactured from the same or similar materials as the predicate devices.
Non-Clinical Testing: The SMR Reverse Shoulder System has undergone fatigue testing to demonstrate both the strength of the humeral stem and the post-fatigue strength of the modular connections; and wear testing of the reverse liner and glenospheres. 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 dcvices. The testing results demonstrated the device's ability to perform under expected clinical conditions.
Traditional 510(k) -SMR Reverse Shoulder System June 10, 2011
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6
111 2098
:
:
. .
. .
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Reverse Shoulder System to the predicate device(s). . ... ... ... ...
・
. . . . . . .
. .
Traditional 510(k) -SMR Reverse Shoulder System June 10, 2011
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