(108 days)
Not Found
No
The document describes a mechanical implant (shoulder system) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implantable shoulder system intended to relieve pain and restore function in individuals with degenerative diseases or fractures of the glenohumeral joint.
No
This device is a shoulder implant system, designed to relieve pain and restore function in individuals with degenerative diseases or fractures of the glenohumeral joint. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "humeral stem" and "components are supplied sterile," indicating a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that the Equinoxe Shoulder System is a surgical implant used to replace or repair the glenohumeral joint and humerus in skeletally mature individuals with specific conditions like degenerative diseases or fractures. It is implanted directly into the body.
Therefore, since the device is an implant used within the body for surgical treatment and not for testing specimens outside the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Equinoxe Shoulder System is indicated to relieve pain and restore function 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.
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
| P | L | Z/R | 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 arthodesis 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 to relieve pain and restore function 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 to relieve pain and restore function 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 with acgestered. It as a superior migration of the humeral head (reverse total shoulder arthroplasty).
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWT, KWS
Device Description
The Equinoxe Platform Fracture Stem is a humeral stem for use in acute fracture of the proximal humerus. The stem is designed to function with the Equinoxe primary shoulder and reverse shoulder components. All components are supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, proximal humerus, humeral head, mid-humerus
Indicated Patient Age Range
skeletally mature individuals
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)
Mechanical tests, engineering analyses, and simulated surgical (sawbones and cadaver) implantations were performed with results demonstrating that the Equinoxe Platform Fracture Stem is substantially equivalent to the identified predicate devices.
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.
K042021, K073688, K062029, K023063, K080642, K060209, K071948
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
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 entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Exactech, Incorporated Mr. Graham L. Cuthbert Regulatory Affairs Specialist II 2320 N. W. 66th Court Gainesville, Florida 32653
Re: K092900
Trade/Device Name: Exactech® Equinoxe® Platform Fracture Stem Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWT, KWT, KWS Dated: December 22, 2009 Received: December 23, 2009
Dear Mr. Cuthbert:
This letter corrects our substantially equivalent letter of January 7, 2010.
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
Page 2 - Mr. Graham L. Cuthbert
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
Exactech® Equinoxe® Platform Fracture Stem Traditional 510(k)
510(k) Number: K092900
Device Name: Exactech® Equinoxe® Platform Fracture Stem
INDICATIONS FOR USE:
The Equinoxe Shoulder System is indicated to relieve pain and restore function 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.
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
| P | L | Z/R | 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 arthodesis 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 to relieve pain and restore function 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 to relieve pain and restore function 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 with acgestered. It as a superior migration of the humeral head (reverse total shoulder arthroplasty).
3
Exactech® Equinoxe® Platform Fracture Stem . Traditional 510(k)
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oputa for mxn
(Division Sign-Off) (Division Sigiron of Surgical, Offhopedic,
Division of Surgical, Offhopedic, Division of Surgers and Restorative Devices
510(k) Number K092900
4
1092900
Exactech® Equinoxe® Platform Fracture Stem Traditional 510(k)
JAN - 7 2010
| Company: | Exactech, Inc |
|---|---|
| Date: | January 5, 2010 |
| Contact Person: | Graham L. Cuthbert, Regulatory Affairs Specialist II |
| Proprietary Name: | Exactech® Equinoxe® Platform Fracture Stem |
| Common Name: | Proximal Humerus Fracture Prosthesis |
| 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) |
Legally Marketed Devices to Which Substantial Equivalence Is Claimed
- Equinoxe Fracture Stem (#K042021) .
- Equinoxe Fracture Humeral Adapter Tray (#K073688) .
- Zimmer Anatomical Shoulder Fracture System (#K062029) ◆
- Biomet Comprehensive Shoulder Fracture System (#K023063) .
- Biomet Comprehensive Reverse Shoulder (#K080642) .
- Tornier Aequalis Shoulder Fracture System & Aequalis Shoulder System (#K060209) .
- Tornier Aequalis Shoulder Reversed Adapter (#K071948) .
Device Description
The Equinoxe Platform Fracture Stem is a humeral stem for use in acute fracture of the proximal humerus. The stem is designed to function with the Equinoxe primary shoulder and reverse shoulder components. All components are supplied sterile.
Indications for Use
The Equinoxe Shoulder System is indicated to relieve pain and restore function 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.
5
197900
Exactech® Equinoxe® Platform Fracture Stem Traditional 510(k)
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
| P | L | 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 to relieve pain and restore function 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 to relieve pain and restore function 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).
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use. Equinoxe Platform Fracture Stem and predicate devices are intended . for use in repairing acute fractures of the proximal humerus and have similar indications for use statements.
- Materials. Equinoxe Platform Fracture Stem and predicate devices are composed of . comparable materials conforming to recognized industry standards for permanent implants.
- Dimensions. Equinoxe Platform Fracture Stem and predicate device components are . available in equivalent size ranges.
6
Exactech® Equinoxe® Platform Fracture Stem Traditional 510(k)
- Sterilization processes. Equinoxe Platform Fracture Stem and predicate devices are . sterilized using equivalent sterilization processes conforming to recognized industry standards.
- Performance specifications. Equinoxe Platform Fracture Stem and predicate devices . conform to recognized performance standards for total shoulder joint replacement devices.
Substantial Equivalence Conclusion
Mechanical tests, engineering analyses, and simulated surgical (sawbones and cadaver) implantations were performed with results demonstrating that the Equinoxe Platform Fracture Stem is substantially equivalent to the identified predicate devices.