(244 days)
No
The document describes a modification to existing shoulder system components and does not mention any AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is a shoulder system indicated for use in individuals with degenerative diseases or fractures of the glenohumeral joint, which aims to treat and restore function, aligning with the definition of a therapeutic device.
No
The device description and intended use indicate that the Equinoxe Shoulder System is an implant used for arthroplasty (surgical replacement of a joint) in individuals with degenerative diseases or fractures of the glenohumeral joint. It is a treatment device, not a diagnostic one.
No
The device description clearly indicates modifications to physical components (replicator plates) of a shoulder implant system, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating degenerative diseases and fractures of the glenohumeral joint. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a shoulder system including humeral stems, glenoids, humeral heads, and replicator plates. These are all components of a surgical implant.
- Anatomical Site: The device is used within the body (glenohumeral joint, humerus). IVDs are used to examine samples from the body.
- Performance Studies: The performance studies described (humeral head pull-off, cadaveric validation) are related to the mechanical and surgical performance of the implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a surgical implant used to replace or repair a joint.
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 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), 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
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.
To restore mobility from previous procedures (e.g. previous fusion)
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 4part 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)
PHX, KWT, KWS, HSD
Device Description
This submission proposes modifying the Exactech Equinoxe Replicator Plates and Fixed Angled Replicator Plates cleared under 510(k) #K042021 and #K102951. The proposed modifications are as follows:
-
- The proposed replicator plates and the fixed angled replicator plates will attach to the humeral head using a morse taper that is half the height of the morse taper of the anatomic replicator plates and fixed angled replicator plates cleared in 510(k) #K042021 and 510(k) #K102951.
The proposed Exactech Equinoxe Replicator Plates, and Fixed Angled Replicator Plates are intended to be used with the same Equinoxe Shoulder system components described in 510(k). #K042021 and #K102951 as cited predicates.
- The proposed replicator plates and the fixed angled replicator plates will attach to the humeral head using a morse taper that is half the height of the morse taper of the anatomic replicator plates and fixed angled replicator plates cleared in 510(k) #K042021 and 510(k) #K102951.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, shoulder joint, humeral head, proximal 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)
- Humeral head pull-off to determine taper engagement strength per ASTM F2009-00 .
- Cadaveric validation to confirm humeral head can be impacted on axis. .
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.
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 features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, layered on top of each other. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
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: K121067
Trade/Device Name: Exactech® Equinoxe® Shoulder System Short Replicator Plates Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWT, KWS, HSD Dated: October 31, 2012 Received: November 6, 2012
Dear Mr. Cuthbert:
This letter corrects our substantially equivalent letter of December 6, 2012.
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 Shoulder System Short Replicator Plates Special 510(k) - Indications for Use
Indications for Use Statement
510(k) Number:
K 121067
Device Name: Exactech® Equinoxe® Shoulder System Short Replicator Plate
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 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), 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 |
3
| Special 510(k) – Indications for Use | |
|---|---|
| Spiral and other fractures of the mid-humerus (in combination with glenohumeral | |
| degenerative diseases) |
Revision of failed previous reconstructions when distal anchorage is required
Exactech® Equinoxe® Shoulder System Short Replicator Plates
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.
To restore mobility from previous procedures (e.g. previous fusion)
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 4part 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 and/or (Part 21 CFR 801 Subpart D)
d
2
2
1
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)
Krishna Asundi for (Division Sign-Off) Division of Orthopedic Devices
2012.12.05 17:26:15 -05'00'
4
Exactech® Equinoxe® Shoulder System Replicator Plates DEC 0 6 2012 Special 510(k) - 510(k) Summary of Safety and Effectiveness
510(k) Summary of Safety and Effectiveness
- Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 377-1140 Fax: (352) 378-2617
FDA Establishment Number 1038671
Contact: Graham L. Cuthbert Regulatory Affairs Specialist II
Date: December 3rd, 2012
Trade or Proprietary or Model Name(s):
Exactech® Equinoxe® Shoulder System Replicator Plate, Short, 1.5mm offset Exactech® Equinoxe® Shoulder System Replicator Plate, Short, 4.5mm offset Exactech® Equinoxe® Shoulder System Fixed Angle Replicator Plate, Short, 0mm offset Exactech® Equinoxe® Shoulder System Fixed Angle Replicator Plate, Short, 1.5mm offset Exactech® Equinoxe® Shoulder System Fixed Angle Replicator Plate, Short, 4.5mm offset
Common Name:
Shoulder Prosthesis
Classification Name:
Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR 888.3650, Class II, Product Code KWT)
Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR Section 888.3660, Product Code KWS)
Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (21 CFR Section 888.3690, Product Code HSD)
5
Exactech® Equinoxe Shoulder System Replicator Plates Special 510(k) - 510(k) Summary of Safety and Effectiveness
Information on devices to which Substantial equivalence is claimed:
| 510(k) | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| Number K042021 | Equinoxe Shoulder System | Exactech, Inc. |
| K102951 | Equinoxe Fixed Angle Replicator Plates | Exactech, Inc. |
Device Description:
This submission proposes modifying the Exactech Equinoxe Replicator Plates and Fixed Angled Replicator Plates cleared under 510(k) #K042021 and #K102951. The proposed modifications are as follows:
-
- The proposed replicator plates and the fixed angled replicator plates will attach to the humeral head using a morse taper that is half the height of the morse taper of the anatomic replicator plates and fixed angled replicator plates cleared in 510(k) #K042021 and 510(k) #K102951.
The proposed Exactech Equinoxe Replicator Plates, and Fixed Angled Replicator Plates are intended to be used with the same Equinoxe Shoulder system components described in 510(k). #K042021 and #K102951 as cited predicates.
- The proposed replicator plates and the fixed angled replicator plates will attach to the humeral head using a morse taper that is half the height of the morse taper of the anatomic replicator plates and fixed angled replicator plates cleared in 510(k) #K042021 and 510(k) #K102951.
Intended Use of the Device:
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 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), and FRACTURE (F) humeral components are as follows:
| P | L | F | Indications |
|---|---|---|---|
| √ | √ | Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative |
6
| Special 510(k) - 510(k) Summary of Safety and Effectiveness |
|---|
| problems |
| √ Congenital abnormalities in the skeletally mature |
Exactech® Equinoxe® Shoulder System Replicator Plates
| √ | 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 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 manure individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4pait 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.
Rationale for Substantial Equivalence:
Intended Use / Indications for Use - Proposed and predicate devices have identical indications for use.
Materials - Proposed and predicate devices are composed of identical biocompatible materials conforming to recognized industry standards for permanent implants.
Design Features - Proposed and predicate devices have the same key design features, and mate with all existing implant and instruments of the Equinoxe shoulder system.
Dimensions - The proposed replicator plates and fixed angled replicator plates have the same dimensions, same taper geometry, and mate with all existing humeral heads; with the exception of the shortened taper height.
Packaging and Sterilization - Proposed and predicate devices are packaged and sterilized using the same materials and processes.
Device Shelf Life - Proposed and predicate devices have the same shelf life.
7
Exactech® Equinoxe® Shoulder System Replicator Plates Special 510(k) - 510(k) Summary of Safety and Effectiveness
Summary of Non-Clinical Performance Data:
- Humeral head pull-off to determine taper engagement strength per ASTM F2009-00 .
- Cadaveric validation to confirm humeral head can be impacted on axis. .
Substantial Equivalence Conclusion:
Test and analysis provided in this 510(k) submission demonstrate that the proposed Exactech Equinoxe Shoulder System Replicator Plates and Fixed Angled Replicator Plates are substantially equivalent to the cleared predicate devices.