(133 days)
No
The summary describes a mechanical prosthesis and its engineering and performance testing, with no mention of AI or ML.
Yes
The device is a prosthesis system intended for use in shoulder arthroplasty to treat various conditions, which aligns with the definition of a therapeutic device designed to alleviate or cure a medical condition.
No.
The device is a prosthesis intended for surgical implantation to replace or reconstruct the proximal humerus, not to diagnose a condition.
No
The device description and performance studies clearly indicate this is a physical prosthesis (implant) and not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for reconstructing the shoulder joint in cases of disease, trauma, or revision. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a prosthesis designed to replace parts of the humerus. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, the Equinoxe Humeral Reconstruction Prosthesis System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Equinoxe Humeral Reconstruction Prosthesis System is inteni or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- · Rheumatoid arthritis
- · Revision where other devices or treatments have failed
- · Correction of functional deformity
- Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
- · Traumatic arthritis
- · Oncology applications including bone loss due to tumor resection.
- · Significant humeral resection which are unmanageable using other treatment methods
The Equinoxe Humeral Reconstruction Prosthesis System can be used in either primary or revision arthroplasty procedures.
The Equinoxe Humeral Reconstruction Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreplaceable and grossly deficient, and a functional deltoid muscle is present.
In the USA, the Equinoxe Humeral Reconstruction Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.
The Equinoxe Humeral Reconstruction Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Humeral Reconstruction Prosthesis Distal Stem Collars are only for uncemented, press-fit use.
Product codes
KWT, KWS, PHX, HSD
Device Description
The proposed Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies represent a modification of the predicate Exactech Equinoxe Humeral Reconstruction Prosthesis Proximal Bodies cleared in K143659. Both the predicate and proposed devices have the same intended use, general design features and basic fundamental scientific technology. The only difference between the predicate and the proposed device is a decreased tuberosity thickness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal humeral
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
Engineering analysis was conducted to evaluate the mechanical properties of the proposed Equinoxe Humeral Reconstruction Prosthesis Extra-Short Proximal Bodies, including: Taper Analysis, Suture Abrasion, Axial Pull-off, Fatigue Testing, Torsion Testing. Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2017
Exactech Inc Thomas Mcnamara Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K162903
Trade/Device Name: Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-small Proximal Bodies Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder Joint Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWT, KWS, PHX, HSD Dated: January 26, 2017 Received: January 30, 2017
Dear Thomas McNamara:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (21 CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
Indications for Use (Describe)
The Equinoxe Humeral Reconstruction Prosthesis System is inteni or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- · Rheumatoid arthritis
- · Revision where other devices or treatments have failed
- · Correction of functional deformity
- Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
- · Traumatic arthritis
- · Oncology applications including bone loss due to tumor resection.
- · Significant humeral resection which are unmanageable using other treatment methods
The Equinoxe Humeral Reconstruction Prosthesis System can be used in either primary or revision arthroplasty procedures.
The Equinoxe Humeral Reconstruction Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreplaceable and grossly deficient, and a functional deltoid muscle is present.
In the USA, the Equinoxe Humeral Reconstruction Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.
The Equinoxe Humeral Reconstruction Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Humeral Reconstruction Prosthesis Distal Stem Collars are only for uncemented, press-fit use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Sponsor: | Exactech®, Inc
2320 NW 66th Court
Gainesville FL, 32653 |
|-------------------|-----------------------------------------------------------------------------------------------------------|
| | Phone: (352) 377-1140 Fax: (352) 378-2617 |
| | FDA Establishment Number 1038671 |
| Date: | January 26, 2017 |
| Contact Person: | Thomas McNamara, RAC
Regulatory Affairs Specialist
Telephone: (352) 327-1140
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small
Proximal Bodies |
| Common Name: | Humeral Stem |
Classification Name:
Shoulder Joint Metal/Polymer Non-Constrained Cemented Prosthesis, (21 CFR Section 888.3650. Class II, Product Code KWT). Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, (21 CFR Section 888.3660, Class II Product Code KWS), Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, (21 CFR Section 888.3660, Class II Product Code PHX) Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis, (21 CFR Section 888.3690, Class II, Product Code HSD)
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| Equinoxe Humeral Reconstruction | ||
| Prosthesis | Exactech, Inc | K143659 |
Indication for Use:
The Equinoxe Humeral Reconstruction Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:
- . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- . Rheumatoid arthritis
- . Revision where other devices or treatments have failed
- . Correction of functional deformity
- . Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
- Traumatic arthritis
4
Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies Traditional 510(k) - 510(k) Summary
- Oncology applications including bone loss due to tumor resection. .
- . Significant humeral resection which are unmanageable using other treatment methods
The Equinoxe Humeral Reconstruction Prosthesis System can be used in either primary or revision arthroplasty procedures.
The Equinoxe Humeral Reconstruction Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreplaceable and grossly deficient, and a functional deltoid muscle is present.
In the USA, the Equinoxe Humeral Reconstruction Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.
The Equinoxe Humeral Reconstruction Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Humeral Reconstruction Prosthesis Distal Stem Collars are only for uncemented, press-fit use.
Device Description
The proposed Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies represent a modification of the predicate Exactech Equinoxe Humeral Reconstruction Prosthesis Proximal Bodies cleared in K143659. Both the predicate and proposed devices have the same intended use, general design features and basic fundamental scientific technology. The only difference between the predicate and the proposed device is a decreased tuberosity thickness.
Testing:
An engineering analysis was conducted to evaluate the mechanical properties of the proposed Equinoxe Humeral Reconstruction Prosthesis Extra-Short Proximal Bodies, including:
- Taper Analysis ●
- Suture Abrasion
- Axial Pull-off ●
- Fatigue Testing ●
- Torsion Testing
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies are substantially equivalent to the cleared Exactech Humeral Reconstruction Proximal Bodies.