(87 days)
Not Found
No
The document describes a mechanical orthopedic implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to treat specific medical conditions such as rheumatoid arthritis, degenerative joint disease, and fractures of the humeral head, with the goal of increasing mobility, stability, and relieving pain.
No
The device is a total shoulder replacement system, which is an implant used for joint replacement, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (humeral stem, humeral head, glenoid) and their material properties and intended use in surgical procedures. There is no mention of software as the primary or sole component.
Based on the provided information, the Nexa Orthopedics Total Shoulder System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a replacement for shoulder joints disabled by various conditions. This is a surgical implant used in vivo (within the body) to restore function and relieve pain.
- Device Description: The description details the physical components of the shoulder system (humeral stem, head, glenoid) and how they are designed to be implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Nexa Orthopedics Total Shoulder System is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional all polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement shoulder system. The Nexa Total Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.
The Nexa Orthopedics Total Shoulder System is indicated for use as a replacement of shoulder joints disabled by the following:
- . Rheumatoid arthritis with pain
- . Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- . Correction of functional deformity
- . Fractures of the humeral head
- . Traumatic arthritis
- Revision of other devices if sufficient bone stock remains .
All components are single use. The humeral stem is intended for cementless use while the all polyethylene glenoid is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KWT, HSD
Device Description
The Nexa Orthopedics Total shoulder system is comprised of a line of humeral stems, humeral heads, and all polyethylene glenoid components. The humeral stems are sized and shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally filling shape, are designed to accommodate the natural humeral geometry and provide stable fixation, proximal bone loading, and proper head placement with 0 to 3 mm of head adjustment possible. The humeral heads are offered with both spherical and non-spherical articulating surfaces and allow both neutral and offset head positioning via offset taper. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the Nexa all polyethylene, cemented glenoid. The glenoid has two or three pegs, depending on size, and is designed to function with both the spherical and non-spherical heads of the Nexa 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Nexa Orthopedics Total Shoulder System components have been evaluated with respect to the following standards:
- ASTM F2009-00 Standard Test Method for Determining the Axial . Disassembly Force of Taper Connections of Modular Prostheses
- . ASTM F2028-02 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation.
- ASTM F1378 05 Standard for Shoulder Implants ●
- ASTM 1044 05 Standard Test Method for Shear testing of Calcium . Phosphate Coatings and Metal Coatings
- . ASTM F-1537-00 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants
- ASTM F1147 -- 05 Standard Test Method for Tension Testing of Calcium . Phosphate and Metallic Coatings
- . ASTM F 136 REV A Standard Specification for Wrought Titanium -6Aluminum - 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM F648-04 Standard Specification for Ultra-High-Molecular-Weight . Polyethylene Powder and Fabricated Form for Surgical Implants
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.
Biomet Bio-Modular Shoulder System (K992119, K992899, K030710, . K032507), Tornier Aequalis Shoulder System (K063081) ., Axiom Orthopaedics Shoulder Resurfacing System (K061862) .
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
510(k) Summary for Nexa Orthopedics Total Shoulder System
SPONSOR 1.
Nexa Orthopedics, Inc. 285 West Side Avenue Suite 251 Jersey City, NJ 07305
Contact Person: Peter Verrillo Telephone: 201-377-9129
Date Prepared: April 04, 2007
DEVICE NAME 2.
| Proprietary Name: | Nexa Orthopedics Total Shoulder System | ||
|---|---|---|---|
| Common/Usual Name: | Total Shoulder Replacement | ||
| Classification Name: | Shoulder joint metal/polymer non-constrained cemented | ||
| prosthesis; | |||
| Shoulder joint metal/polymer semi-constrained cemented | |||
| prosthesis; | |||
| Shoulder joint humeral (hemi-shoulder) metallic | |||
| uncemented prosthesis. |
3. PREDICATE DEVICES
- Biomet Bio-Modular Shoulder System (K992119, K992899, K030710, . K032507)
- Tornier Aequalis Shoulder System (K063081) .
- Axiom Orthopaedics Shoulder Resurfacing System (K061862) .
1
4. DEVICE DESCRIPTION
The Nexa Orthopedics Total shoulder system is comprised of a line of humeral stems, humeral heads, and all polyethylene glenoid components. The humeral stems are sized and shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally filling shape, are designed to accommodate the natural humeral geometry and provide stable fixation, proximal bone loading, and proper head placement with 0 to 3 mm of head adjustment possible. The humeral heads are offered with both spherical and non-spherical articulating surfaces and allow both neutral and offset head positioning via offset taper. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the Nexa all polyethylene, cemented glenoid. The glenoid has two or three pegs, depending on size, and is designed to function with both the spherical and non-spherical heads of the Nexa system.
5. INTENDED USE
The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional glenoid component. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Nexa Total Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff where it will provide increased mobility and stability as well as reduced pain.
The Nexa Orthopedics Total Shoulder System is indicated for use as a replacement of shoulder joints disabled by the following:
- Rheumatoid arthritis with pain .
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and . avascular necrosis)
- . Correction of functional deformity
- Fractures of the humeral head .
- Traumatic arthritis
- Revision of other devices if sufficient bone stock remains .
All components are single use. The humeral stem is intended for cemented or cementless use, while the glenoid is intended for cemented use only.
2
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The proposed Nexa Total Shoulder System and the predicate devices are equivalent in that they all consist of humeral stems, humeral heads, and optional all polyethylene glenoid components. The proposed humeral stems, humeral heads, and glenoid components are equivalent to their predicates in that they are composed of TikAlaV, CoCrMo, and Ultra High Molecular Weight Polyethylene respectively.
Similarly, both the proposed products and their predicate devices have been designed to mimic the normal humeral canal, humeral head, or glenoid sizing and shape appropriately. Therefore, both the proposed and predicate devices are available in a variety of stem, head, and glenoid sizes.
Furthermore, as with their predicates, the Nexa humeral stem may be press fit, or cemented, while the glenoid is for cemented use only.
7. PERFORMANCE TESTING
The Nexa Orthopedics Total Shoulder System components have been evaluated with respect to the following standards:
- ASTM F2009-00 Standard Test Method for Determining the Axial . Disassembly Force of Taper Connections of Modular Prostheses
- . ASTM F2028-02 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation.
- ASTM F1378 05 Standard for Shoulder Implants ●
- ASTM 1044 05 Standard Test Method for Shear testing of Calcium . Phosphate Coatings and Metal Coatings
- . ASTM F-1537-00 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants
- ASTM F1147 -- 05 Standard Test Method for Tension Testing of Calcium . Phosphate and Metallic Coatings
- . ASTM F 136 REV A Standard Specification for Wrought Titanium -6Aluminum - 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM F648-04 Standard Specification for Ultra-High-Molecular-Weight . Polyethylene Powder and Fabricated Form for Surgical Implants
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, flowing design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 2007
Nexa Orthopedics, Inc % Ms. Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K071147
Trade/Device Name: Nexa Orthopedics Total Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: KWT, HSD Dated: April 4, 2007 Received: April 24, 2007
Dear Ms. McNamara-Cullinane:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Page 2 - Ms. Mary McNamara-Cullinane
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehly
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Nexa Orthopedics Total Shoulder System
Indications for Use:
The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional all polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement shoulder system. The Nexa Total Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.
The Nexa Orthopedics Total Shoulder System is indicated for use as a replacement of shoulder joints disabled by the following:
- . Rheumatoid arthritis with pain
- . Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- . Correction of functional deformity
- . Fractures of the humeral head
- . Traumatic arthritis
- Revision of other devices if sufficient bone stock remains .
All components are single use. The humeral stem is intended for cementless use while the all polyethylene glenoid is intended for cemented use only.
| Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) |
|---|---|---|---|
| ---------------------------------------------- | --- | -------- | --------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| Nexa Orthopedics 510(k) Total Shoulder System | April 4, 2007 | |
|---|---|---|
| 510(k) Number | K071147 | Page vi |