(18 days)
No
The summary describes a mechanical implant system for shoulder arthroplasty and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to relieve pain and restore function in individuals with degenerative diseases or fractures of the glenohumeral joint, which are therapeutic goals.
No
The Equinoxe™ Shoulder System is an orthopedic implant designed to relieve pain and restore function in individuals with degenerative diseases or fractures of the glenohumeral joint. Its purpose is treatment through arthroplasty, not diagnosis.
No
The device description clearly outlines physical components (humeral stems, glenoids) intended for surgical implantation, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- Device Description and Intended Use: The Equinoxe™ Shoulder System is a surgical implant (a prosthetic joint) intended to be surgically implanted into the human body to replace or repair the glenohumeral joint. Its purpose is to relieve pain and restore function, not to analyze biological specimens.
- Lack of Specimen Analysis: The description and intended use do not mention any analysis of biological samples or any diagnostic testing performed outside of the body.
Therefore, the Equinoxe™ Shoulder System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EquinoxeTM 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/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 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) |
Product codes
KWS, HSD
Device Description
The cemented primary humeral stem, long/revision stem, fracture stem, and both the pegged and keeled glenoids are intended for cemented fixation only. The press-fit stems are intended for press-fit applications but may be used with bone cement if deemed appropriate by the surgeon. The long/revision stem is advised when the distal bone quality is insufficient to adequately anchor the primary stems (typically as a result of mid-humeral fractures). The fracture stem is advised for 3 & 4 part fractures of the proximal humerus. 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, humeral, humerus
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
surgeon
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)
Engineering evaluations were conducted verifying the proposed Equinoxe Press-Fit Humeral Stems and the Equinoxe Cemented Revision Humeral Long Stems are appropriate for anticipated in vivo use and are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
2320 NW 66TH COURT GAINESVILLE, FL 32653
2-377-1140
Exactech, Inc.® Equinoxe Shoulder Stem Size Scope Extension Special 510(k) Summary of Safety and Effectiveness
JUN 1 2 2006
-
- Submitted By: Exactech, Inc. 2320 N.W. 66th Court Gainesville, FL 32653
- Contact: Chris Roche Product Development Engineer Exactech, Inc. 2320 N.W. 66th Court Gainesville, FL 32653 Phone: (352) 377-1140 Fax: (352) 378-2617
- Exactech Equinoxe® Shoulder System 3. Product:
21 CFR Section 888.3660 Product Code 87 KWS Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Cemented
21 CFR Section 888.3690 Product Code 87 HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic, Cemented or Uncemented
Class II
Rev 04/24/06
Section 4 Page 1 of 2
1
Image /page/1/Picture/0 description: The image shows the word "Exactech" in a stylized font. The word is white and the background is black. There is a circle with a "C" in it to the left of the word. There is a registered trademark symbol to the right of the word.
352-377-1140 FAX 352-378-2617
Exactech, Inc. ® Equinoxe" Shoulder Stem Size Scope Extension Special 510(k) Summary of Safety and Effectiveness
Trade or Proprietary or Model Name(s):
Equinoxe Press-Fit Primary Humeral Stems (size17x125 and 19x130) Equinoxe Cemented Revision Humeral Long Stems (size 10x200mm, 12x200mm)
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| #K042021 | Equinoxe Press-Fit Primary Humeral Stems | |
| (Size 7x100mm, 9x105mm, 11x110mm, 13x115mm, | ||
| 15x120mm) | Exactech, Inc. | |
| #K042021 | Equinoxe Cemented Revision Humeral Long Stems | |
| (Size 8x175mm, 8x215mm) | Exactech, Inc. |
Intended Use:
The cemented primary humeral stem, long/revision stem, fracture stem, and both the pegged and keeled glenoids are intended for cemented fixation only. The press-fit stems are intended for press-fit applications but may be used with bone cement if deemed appropriate by the surgeon. The long/revision stem is advised when the distal bone quality is insufficient to adequately anchor the primary stems (typically as a result of mid-humeral fractures). The fracture stem is advised for 3 & 4 part fractures of the proximal humerus. All components are supplied sterile.
Special 510(k) Modifications:
- Addition of 17 x 125 and 19 x 130mm Press-Fit Primary Humeral Stem size ●
- Addition of 10 x 200 and 12 x 200 Cemented Revision Humeral Long Stems .
- . Increased lateral offset for sizes 11,12,13,15
Conclusions:
Engineering evaluations were conducted verifying the proposed Equinoxe Press-Fit Humeral Stems and the Equinoxe Cemented Revision Humeral Long Stems are appropriate for anticipated in vivo use and are substantially equivalent to the predicate devices.
Rev 04/24/06
Section 4 Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2006
Exactech, Inc. % Ms. Maritza Elias Regulatory Representative 2320 NW 66th Court Gainesville, Florida 32653
Re: K061454
Trade/Device Name: Exactech Equinoxe® Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS, HSD Dated: April 24, 2006 Received: May 25, 2006
Dear Ms. Elias:
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
3
Page 2 - Ms. Maritza Elias
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. 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,
Helmut Remensno
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exactech, Inc.® Equinoxe® Shoulder Stem Size Scope Extension Special 510(k) Indications for Use
510(k) Number: ______________________________________________________________________________________________________________________________________________________________________________
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/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 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) |
| Prescription Use | X |
|---|---|
| or | Over the Counter Use |
(Division Sign-Off)
Please do not write below this line - use another page if needed.
Division of General, Restorative,
Concurrence of CDRH, Office of Device Evaluation (ODE)
and Neurological Devices
| 06/06/06 | 510(k) Number K061454 |
|---|---|
| Section 3 Page 1 of 1 |