(303 days)
Not Found
No
The document describes a mechanical shoulder 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 a system of glenohumeral prostheses designed for joint replacement procedures, which are inherently therapeutic in nature by treating degenerative diseases, fractures, and other pathologies of the shoulder joint.
No
Explanation: The device is an orthopedic implant (shoulder system) used for joint replacement procedures, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like humeral stems, heads, glenoids, plates, and screws, made of materials like UHMWPE and titanium. 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The text clearly describes the Equinoxe Shoulder System as a system of implants (humeral stems, heads, glenoids, etc.) designed for surgical implantation to replace or repair the glenohumeral joint.
- Intended Use: The intended use is for surgical treatment of degenerative diseases or fractures of the glenohumeral joint. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
- The cemented primary humeral stem, long/revision stem, fracture stems and all . Equinoxe glenoids are intended for cemented fixation.
- The press-fit humeral stems are intended for press-fit applications but may be used ● with bone cement at the discretion the surgeon.
- The reverse humeral components are intended to be used in cemented applications . or in revision cascs when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
- Humeral Heads are intended for use in cemented and press-fit applications.
Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows:
rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
congenital abnormalities in the skeletally mature
primary and secondary necrosis of the humeral head.
humeral head fracture with displacement of the tuberosities
pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
displaced three-part and four-part upper humeral fractures
spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
revision of failed previous reconstructions when distal anchorage is required
to restore mobility from previous procedures (e.g. previous fusion)
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative discases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KWS, KWT
Device Description
The Equinoxe Shoulder System comprises both cemented and press-fit semi-constrained glenohumeral prostheses for use in hemi-shoulder and total-shoulder joint replacement procedures and a cemented semi-constrained glenohumeral fracture prosthesis for use in fractures of the proximal humerus. The system includes various sizes and types of modulat humeral stems, humeral heads, glenoids, replicator plates, and screws for use in primary, revision, and fracture applications.
The Equinoxe Caged Glenoids are designed to interface and articulate with the Equinoxe total-shoulder system. They are composed of an Ultra High Molecular Weight Polyethylene (UHMWPE) articulating surface modularly connected to a grit blasted titanium (Ti-6Al-4V) bone cage and three grit blasted titanium (Ti-6Al-4V) pegs. A posterior augment version of this cage glenoid is provided to preserve bone by limiting the amount of eccentric glenoid reaming necessary to correct the patient's glenoid version. All components are supplied sterile.
The Equinoxe XL Keeled and XL Pegged Glenoids are designed to interface and articulate with the 47, 50, & 53 mm humeral head from the Equinoxe total-shoulder system. The subject devices are a modification of the previously cleared Equinoxe cemented keeled and pegged glenoids (#K042021). All components are supplied sterile.
Additionally, this "Traditional" 510(k) proposes several modifications to our previously cleared Equinoxe cemented keeled and pegged glenoids. Specifically: 1) an addition of an XL keeled and pegged glenoid size, 2) a decrease in minimum UHMWPE thickness from 5mm to 4mm, 3) a modification in machining pattern on the backside surface (change from horizontal grooves to radial grooves that follow the profile of the device), and 4) a decrease in edge radius around each fixation surface from 0.047 inches to 0.031 inches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head, proximal humerus, shoulder
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
surgeon, orthopaedic surgeon / 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)
Literature reviews, finite element analyses, mechanical tests (edge loading and displacement studies, wear, thermal expansion and disassembly force), engineering analyses, biocompatibility studies and simulated surgical (sawbones and cadaver) implantations were conducted to demonstrate the safety and effectiveness of the Exactech Equinoxe Cage Glenoids, the Exactech Equinoxe XL Keeled and XL Pegged Glenoids in support of the claim of substantial equivalence to the predicates listed above.
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.
K981487, K081707, K955767, K070565, K060694, K042021, K994393
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
| K093430 | |||
|---|---|---|---|
| r-1/4 | |||
| I. Submitter Information | |||
| Company: | Exactech, Inc | ||
| 2320 NW 66th Court | |||
| Gainesville, FL 32653 | |||
| 800-392-8711 | SEP | 2 2010 | |
| Date: | August 31, 2010 | ||
| Contact Person: | |||
| Graham L. Cuthbert Regulatory Affairs Specialist II | |||
| II. Device Information | |||
| Proprietary Name: | Exactech Equinoxe® Cage Glenoid™ | ||
| Exactech Equinoxe® XL Keeled & XL Pegged Glenoid | |||
| Common Name: | Glenoid Component | ||
| Classification Name: | Shoulder joint metal/polymer non-constrained cemented | ||
| prosthesis (21 CFR 888.3650, Class II, Product Code KWT) | |||
| Prosthesis, Shoulder, Semi-constrained, metal/polymer | |||
| cemented (21 CFR 888.3660, Class II, Product Code KWS) |
Of
Legally Marketed Devices to Which Substantial Equivalence Is Claimed III. Exactech Equinoxe Cage Glenoid
- Depuy Anchor Peg Glenoid #K981487 .
- Tornier Affiniti Glenoid #K081707 .
- Smith and Nephew Cofield Glenoid: #K955767 and #K070565. .
- Biomet Modular Hybrid Glenoid: #K060694 ●
Exactech Equinoxe XL Keeled and XL Pegged Glenoid
- Exactech Equinoxe Glenoids: #K042021 .
- Tornier Acqualis Glenoids: #K994393 .
- t Depuy Global Glenoids: #K981487
Device Description IV.
The Equinoxe Shoulder System comprises both cemented and press-fit semi-constrained glenohumeral prostheses for use in hemi-shoulder and total-shoulder joint replacement procedures and a cemented semi-constrained glenohumeral fracture prosthesis for use in fractures of the proximal humerus. The system includes various sizes and types of modulat humeral stems, humeral heads, glenoids, replicator plates, and screws for use in primary, revision, and fracture applications.
Exactech Equinoxe Cage Glenoid
The Equinoxe Caged Glenoids are designed to interface and articulate with the Equinoxe total-shoulder system. They are composed of an Ultra High Molecular Weight Polyethylene (UHMWPE) articulating surface modularly connected to a grit blasted titanium (Ti-6Al-4V) bone cage and three grit blasted titanium (Ti-6Al-4V) pegs. A posterior augment version of
1
K093430
p. 2/4
this cage glenoid is provided to preserve bone by limiting the amount of eccentric glenoid reaming necessary to correct the patient's glenoid version. All components are supplied sterile.
Exactech Equinoxe XL Keeled an XL Pegged Glenoid
The Equinoxe XL Keeled and XL Pegged Glenoids are designed to interface and articulate with the 47, 50, & 53 mm humeral head from the Equinoxe total-shoulder system. The subject devices are a modification of the previously cleared Equinoxe cemented keeled and pegged glenoids (#K042021). All components are supplied sterile.
Additionally, this "Traditional" 510(k) proposes several modifications to our previously cleared Equinoxe cemented keeled and pegged glenoids. Specifically: 1) an addition of an XL keeled and pegged glenoid size, 2) a decrease in minimum UHMWPE thickness from 5mm to 4mm, 3) a modification in machining pattern on the backside surface (change from horizontal grooves to radial grooves that follow the profile of the device), and 4) a decrease in edge radius around each fixation surface from 0.047 inches to 0.031 inches.
V. Indications Use
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
- The cemented primary humeral stem, long/revision stem, fracture stems and all . Equinoxe glenoids are intended for cemented fixation.
- The press-fit humeral stems are intended for press-fit applications but may be used ● with bone cement at the discretion the surgeon.
- The reverse humeral components are intended to be used in cemented applications . or in revision cascs when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
- Humeral Heads are intended for use in cemented and press-fit applications. .
Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows:
| P | L/R | F | Indications |
|---|---|---|---|
| √ | √ | rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems | |
| √ | √ | congenital abnormalities in the skeletally mature | |
| √ | primary and secondary necrosis of the humeral head. | ||
| √ | √ | humeral head fracture with displacement of the tuberosities | |
| √ | √ | pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable | |
| √ | √ | revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved) | |
| √ | displaced three-part and four-part upper humeral fractures | ||
| √ | spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) |
2
| √ | revision of failed previous reconstructions when distal anchorage is required | |
|---|---|---|
| √ | √ | to restore mobility from previous procedures (e.g. previous fusion) |
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
VI. Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
Exactech Equinoxe Cage Glenoid
- Intended Use. Exactech Equinoxe Cage Glenoids and predicate devices are intended . for use in Total Shoulder Arthroplasty. The Equinoxe cage glenoids and posterior augment cage glenoids are intended for cemented fixation.
- Materials. Exactech Equinoxe Cage Glenoids and predicate devices are composed of t equivalent materials conforming to recognized industry standards for permanent implants.
- Dimensions. Exactech Equinoxe Cage Glenoids and predicate devices are available in . equivalent size ranges.
- Sterilization processes. Exactech Equinoxe Cage Glenoids and predicate devices are . sterilized using equivalent sterilization processes conforming to recognized industry standards.
- Performance specifications. Exactech Equinoxe Cage Glenoids and predicate devices . conform to recognized performance standards for total shoulder joint replacement devices.
Exactech Equinoxe XL Keeled and XL Pegged Glenoid
- Intended Use. Exactech Equinoxe XL Keeled, XL Pegged Glenoid and predicate . devices are intended for use in Total Shoulder Arthroplasty. The XL keeled and pegged glenoids are intended for cemented fixation.
- Materials. Exactech Equinoxe XL Keeled, XL Pegged Glenoid and predicate devices . composed of equivalent materials conforming to recognized industry standards for permanent implants.
3
p. 4/4
- Dimensions. Exactech Equinoxe XL Keeled, XL Pegged Glenoid and predicate devices . are available in equivalent size ranges.
- Sterilization processes. Exactech Equinoxe XL Keeled, XL Pegged Glenoid and . predicate devices are sterilized using equivalent sterilization processes conforming to recognized industry standards.
- Performance specifications. Exactech Equinoxe XL Keeled, XL Pegged Glenoid and . predicate devices conform to recognized performance standards for total shoulder joint replacement devices.
Summary of Non-Clinical Performance Data
Literature reviews, finite element analyses, mechanical tests (edge loading and displacement studies, wear, thermal expansion and disassembly force), engineering analyses, biocompatibility studies and simulated surgical (sawbones and cadaver) implantations were conducted to demonstrate the safety and effectiveness of the Exactech Equinoxe Cage Glenoids, the Exactech Equinoxe XL Keeled and XL Pegged Glenoids in support of the claim of substantial equivalence to the predicates listed above.
Substantial Equivalence Conclusion
Results from these tests and analyses provided within this 510(k) demonstrate that the Exactech Equinoxe Cage Glenoids, XL Keeled glenoids, XL Pegged Glenoids and the modified cemented keeled and pegged glenoids are substantially equivalent to the identified predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Exactech, Inc. % Mr. Graham L. Cuthbert Regulatory Affairs Specialist II 2320 NW 66th Court Gainesville, Florida 32653
2 2010 SEP
Re: K093430
Trade/Device Name: Exactech Equinoxe XL Keeled, XL Pegged and Cage Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS. KWS. KWT Dated: August 19, 2010 Received: August 24, 2010
Dear Mr. Cuthbert:
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. Iisting 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
5
Page 2 - Mr. Graham L. Cuthbert
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.
Pavare Buehukb
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
p-1/2
Exactech®, Inc. Indications for Use
510(k) Number:
Device Name:
Exactech Equinoxe® XL Keeled, XL Pegged and Cage GlenoidTM
INDICATIONS FOR USE:
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
- The cemented primary humeral stem, long/revision stem, fracture stems and all . Equinoxe glenoids are intended for cemented fixation.
- The press-fit humeral stems are intended for press-fit applications but may be used . with bone cement at the discretion the surgeon.
- The reverse humeral components are intended to be used in cemented applications . or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
- Humeral Heads are intended for use in cemented and press-fit applications. .
Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows:
| P | L/R | F | Indications |
|---|---|---|---|
| √ | √ | rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic | |
| degenerative problems | |||
| √ | √ | congenital abnormalities in the skeletally mature | |
| √ | primary and secondary necrosis of the humeral head. | ||
| √ | √ | humeral head fracture with displacement of the tuberosities | |
| √ | √ | pathologies where arthrodesis or resectional arthroplasty of the humeral | |
| head are not acceptable | |||
| √ | √ | revisions of humeral prostheses when other treatments or devices have | |
| failed (where adequate fixation can be achieved) | |||
| √ | displaced three-part and four-part upper humeral fractures | ||
| √ | √ | spiral and other fractures of the mid-humerus (in combination with | |
| glenohumeral degenerative diseases) | |||
| √ | √ | revision of failed previous reconstructions when distal anchorage is | |
| required | |||
| √ | √ | √ | to restore mobility from previous procedures (e.g. previous fusion) |
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative discases of the glenohumeral joint and a grossly deficient, irreparable
7
P.2/2
rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
| Prescription Use | X |
|---|---|
| (Per CFR 801.109) |
or
| Over-the-counter Use | |
|---|---|
| ---------------------- | -- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
K093430
(Division Sign-Off) Valtine Prechus forger
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number