(259 days)
Not Found
No
The description focuses on the mechanical components and materials of a shoulder implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a shoulder joint replacement system, which falls under the category of therapeutic devices as it treats conditions like osteoarthritis, avascular necrosis, rheumatoid arthritis, and acute fractures of the humeral head by restoring joint function.
No
The device is a system for primary shoulder joint replacement, which is a therapeutic intervention, not a diagnostic tool.
No
The device description clearly outlines multiple physical components made of materials like Ti6Al4V, CoCrMo, and UHMWPE, which are surgically implanted. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "partial or total primary shoulder joint replacement." This is a surgical procedure involving the implantation of a medical device into the body.
- Device Description: The device components (humeral stem, humeral body, adaptor taper, humeral head, glenoid component) are all physical implants designed to replace parts of the shoulder joint.
- Lack of IVD Characteristics: The description does not mention any components or processes related to testing samples taken from the body (like blood, urine, tissue) to diagnose a condition or monitor health. IVDs are used in vitro (outside the body) for diagnostic purposes.
This device is clearly a surgical implant used for orthopedic reconstruction.
N/A
Intended Use / Indications for Use
The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented applications.
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
Product codes (comma separated list FDA assigned to the subject device)
KWT, HSD
Device Description
The SMR Shoulder System consists of a humeral stem, a humeral body, an adaptor taper, a humeral head and a glenoid component. Components are offered for cemented use for hemi or total shoulder joint arthroplasty, in primary trauma surgery.
Humeral stems are designed for cemented use and are characterized by an outline with a triple conicity to provide optimal fixation and fit independent of canal morphology. The stems are made from Ti6Al4V (ISO 5832-3, ASTM F1472). The surface in contact with cement is polished to reduce shear stresses on the cement mantle and avoid abrasion resulting from micromovements at the stem-cement interface. The distal part of the stems is characterized by a cylindrical cross-section while the proximal part is fluted to prevent rotation of the component relative to bone. The stems are provided with a male Morse taper in the proximal part for coupling with the humeral body.
Humeral bodies are made from Ti6Al4V and are coupled with the humeral stem via a female Morse-taper connection; a locking screw is provided to aid in initial mating of the stem / body assembly. Cylindrical marks are designed at the base of the Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morsetaper connection is designed for the coupling between the humeral body and the humeral head by means of specific adaptor tapers: an angle of 45° between the axis of this Morsetaper and the axis of the stem gives the correct varus-valgus alignment to the joint. A system of holes on the external surface allows anatomical attachment of tuberosities using sutures or wires in trauma applications.
Adaptor tapers (neutral and eccentrical with different heights), are made from Ti6Al4V. They allow coupling between the humeral body and the humeral head. These devices are designed to adjust the centre of rotation of the joint and provide the required offset to the humeral head to achieve the correct tensioning to the soft tissues, optimizing joint stability.
The humeral heads are made from CoCrMo (ISO 5832-12, ASTM F1537). They are intended to articulate with the glenoid bone in hemi-arthroplasty or with the glenoid component in total shoulder arthroplasty. The surface is polished to aid in the reduction of wear.
The glenoid components are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head, which allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation.
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: The SMR Shoulder System has undergone static pull-out and/or torsional testing of all modular connections; fatigue testing to demonstrate both the strength of the humeral stem and the post-fatigue strength of the modular connections; static shear and torsional testing of the glenoid component; and fatigue testing of the glenoid component. 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).
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
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
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K100858
DEC 1 0 2010
Summary of Safety and Effectiveness
Date: October 12, 2010
Manufacturer: Lima-Lto 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 Shoulder System | KWT | Shoulder joint metal/polymer non-constrained |
| cemented prosthesis per 21 CFR 888.3650 | ||
| HSD | Shoulder joint humeral (hemi-shoulder) metallic | |
| uncemented prosthesis per 21 CFR 888.3690 |
Device Description:
The SMR Shoulder System consists of a humeral stem, a humeral body, an adaptor taper, a humeral head and a glenoid component. Components are offered for cemented use for hemi or total shoulder joint arthroplasty, in primary trauma surgery.
Humeral stems are designed for cemented use and are characterized by an outline with a triple conicity to provide optimal fixation and fit independent of canal morphology. The stems are made from Ti6Al4V (ISO 5832-3, ASTM F1472). The surface in contact with cement is polished to reduce shear stresses on the cement mantle and avoid abrasion resulting from micromovements at the stem-cement interface. The distal part of the stems is characterized by a cylindrical cross-section while the proximal part is fluted to prevent rotation of the component relative to bone. The stems are provided with a male Morse taper in the proximal part for coupling with the humeral body.
Humeral bodies are made from Ti6Al4V and are coupled with the humeral stem via a female Morse-taper connection; a locking screw is provided to aid in initial mating of the stem / body assembly. Cylindrical marks are designed at the base of the Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morsetaper connection is designed for the coupling between the humeral body and the humeral head by means of specific adaptor tapers: an angle of 45° between the axis of this Morsetaper and the axis of the stem gives the correct varus-valgus alignment to the joint. A system of holes on the external surface allows anatomical attachment of tuberosities using sutures or wires in trauma applications.
Traditional 510(k) - SMR Shoulder System October 12, 2010
Company Confidential Page 2 - Section 5
1
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K100858
Adaptor tapers (neutral and eccentrical with different heights), are made from Ti6Al4V. They allow coupling between the humeral body and the humeral head. These devices are designed to adjust the centre of rotation of the joint and provide the required offset to the humeral head to achieve the correct tensioning to the soft tissues, optimizing joint stability.
The humeral heads are made from CoCrMo (ISO 5832-12, ASTM F1537). They are intended to articulate with the glenoid bone in hemi-arthroplasty or with the glenoid component in total shoulder arthroplasty. The surface is polished to aid in the reduction of wear.
The glenoid components are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head, which allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation.
Intended Use / Indications:
The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented applications.
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
Predicate Devices:
- Promos modular shoulder system (PlusOrthopedics, K063578) .
- . Anatomical shoulder system (Centerpulse, K030259)
- Modular shoulder system (Acumed, K992525) ●
Comparable Features to Predicate Device(s):
The SMR Shoulder System is similar to the predicate devices in terms of intended use, indications, design and materials. The SMR Shoulder System and the predicates are all intended for partial or total primary shoulder joint replacement. The SMR humeral stems are intended for cemented use only while some of the predicate humeral stems are intended for cemented or cementless use. The SMR and predicate glenoids are all intended for cemented
Traditional 510(k) - SMR Shoulder System October 12, 2010
Company Confidential Page 3 - Section 5
2
use only. The indications of all of the systems are similar with the exception that the SMR Shoulder System is not indicated for revision procedures.
Like the Promos Modular and Acumed Modular Shoulder Systems, the SMR Shoulder System provides modular humeral stem and humeral body components. The Anatomical Shoulder System is designed as a one-piece humeral stem / body component. The SMR Shoulder System and the Promos Modular Shoulder System include modular adaptor tapers for adjustment of the humeral head. The Anatomical Shoulder System and the Acumed Modular Shoulder System do not include adaptor tapers.
The components of the SMR Shoulder System are manufactured from the same or similar materials as the predicate devices. The SMR, Promos and Acumed humeral stems are manufactured from Ti6A14V while the Anatomical cemented humeral stems are manufactured from cast CoCrMo.
Non-Clinical Testing: The SMR Shoulder System has undergone static pull-out and/or torsional testing of all modular connections; fatigue testing to demonstrate both the strength of the humeral stem and the post-fatigue strength of the modular connections; static shear and torsional testing of the glenoid component; and fatigue testing of the glenoid component. 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 Shoulder System October 12, 2010
Company Confidential Page 4 - Section 5
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Lima-Lto- S.P.A % Hastings Regulatory Consulting, LLC. Ms. Cheryl Hastings Principal Consultant P.O. Box 696 Winona Lake, Indiana 46590
DEC 1 0 2010
Re: K100858
Trade/Device Name: SMR Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: 21 CF R 80015860
Regulation Name: Shoulder joint metal/polymer non constrained cemented prothesis Regulatory Class: Class II Product Code: KWT, HSD Dated: November 9, 2010 Received: November 12, 2010
Dear Ms. Hastings:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premaint is substantially equivalent (for the indications
referenced above and have determined the device is subsess marketed in interst for use stated in the enclosure) the arrested predicate devices marketed in interstate for use stated in the encrosuly manoned people to the Medical Device Amendments, or to commerce prior in May 28, 1970, the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval contraks approval provision and Cosment Act (Act) that to hot require approval controls provisions of the Act. The Act. The You may, therefore, market the device, belyev to the governments for among mishranding and general controls provisions of the frectined of the adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
and he If your device is classified (Sec aros). Existing major regulations affecting your device can be
may be subject to additional controls. may be subject to additional controls: Existing Mayor of 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Forts 800 to 898. Register found in the Code of Federal Regarations, Four device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substitution with other requirements of the Act
that FDA has made a determination that your device and agencies. You must that FDA has made a delemination inal your are rederal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not reporting of medical comply with all the Act Stequirements, and more reporting (teporting of medical
CFR Part 807); labeling (21 CFR Part 800); medical device requirements as CFR Part 807); labeling (21 CFR Part 807); incultur are repeative requirements as set
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as
4
Page 2 – Ms. Cheryl Hastings
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.
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
ly of the specific advice of any and and and CDDLUGDRUOfficae(vem 115800 h go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/Offices/ucm115809.html for and go to http://www.fda.gov/AboulrDA/Cchicr.sOffices Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. (21CFP P the Center for Devices and Radionogical realing by reference to premarket notification" (2) (CFR Patt note the regulation entitled, "Misoranding of reference to premaint of the MDR regulation (21 CFR Part 803), please go to
CFR Part 803), please go to http://www.ida.gov/wiodiatics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general information on your responsibility of the manager Division of Sman Manazones - 100 or at its Internet address (800) 038-2041 01 (301) 770-1100 et an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an
Sincerely yours,
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): Unknown
Device Name: SMR Shoulder System
DEC 1 0 2010
Indications for Use:
SMR Shoulder System Indications for Use
The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented applications.
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
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)
for Mr. Melkerson
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
K100858 510(k) Number
Traditional 510(k) - SMR Shoulder System March 15, 2010
Company Confidential Section 4 - Page 15 of 279