K Number
K162325
Device Name
Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw
Manufacturer
Date Cleared
2017-03-06

(199 days)

Product Code
Regulation Number
888.3660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The proposed Exactech Equinoxe Reverse Shoulder Compression Screws. Glenosphere Locking Screw, and Locking Cap devices represent a modification of the predicate Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap (K063569 and K110708) used in reverse shoulder arthroplasty. All devices were cleared via 510(k) K063569 except the 50mm and 54mm Equinoxe Reverse Shoulder Compression Screws. These sizes were cleared via 510(k) K110708. The only difference between the proposed Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap and predicate Equinoxe Compression Screws, Glenosphere Locking Screw, and Locking Cap is the sterilization method. The predicate compression screws, glenosphere locking screw, and locking cap are provided sterile via gamma radiation. The modified compression screws, glenosphere locking screw, and locking cap will be supplied non-sterile and must be sterilized by steam sterilization in a separately provided re-usable sterilization container prior to implantation. Cleaning and sterilization instructions are provided in the package insert for the Equinoxe Reverse Shoulder System Screw Components.
More Information

No
The summary describes a modification to existing shoulder implant components related to sterilization methods. There is no mention of AI or ML in the intended use, device description, or performance studies.

Yes
The Equinoxe Reverse Shoulder System is an implant indicated for treating degenerative diseases of the glenohumeral joint and failed glenohumeral joint replacements, which directly addresses disease and aims to restore function.

No
The device, Equinoxe Reverse Shoulder System, is an implantable medical device used in surgery to replace a damaged glenohumeral joint. It treats a condition rather than diagnosing it.

No

The device description clearly states it is a modification of physical components (compression screws, glenosphere locking screw, and locking cap) used in reverse shoulder arthroplasty, and the primary change is the sterilization method. This indicates a hardware device, not software.

No, 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: The provided text describes a system of implants (screws, glenosphere locking screw, locking cap) intended for surgical implantation in the shoulder joint.
  • Intended Use: The intended use is for treating degenerative diseases and failed joint replacements in the glenohumeral joint. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.

The device is a surgical implant, not a diagnostic tool.

N/A

Intended Use / Indications for Use

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.

Product codes

PHX, KWT, KWS

Device Description

The proposed Exactech Equinoxe Reverse Shoulder Compression Screws. Glenosphere Locking Screw, and Locking Cap devices represent a modification of the predicate Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap (K063569 and K110708) used in reverse shoulder arthroplasty. All devices were cleared via 510(k) K063569 except the 50mm and 54mm Equinoxe Reverse Shoulder Compression Screws. These sizes were cleared via 510(k) K110708. The only difference between the proposed Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap and predicate Equinoxe Compression Screws, Glenosphere Locking Screw, and Locking Cap is the sterilization method. The predicate compression screws, glenosphere locking screw, and locking cap are provided sterile via gamma radiation. The modified compression screws, glenosphere locking screw, and locking cap will be supplied non-sterile and must be sterilized by steam sterilization in a separately provided re-usable sterilization container prior to implantation. Cleaning and sterilization instructions are provided in the package insert for the Equinoxe Reverse Shoulder System Screw Components.

Both the predicate and modified devices share the following similarities:

  • The same indications for use ●
  • The same intended use ●
  • The same materials ●
  • The same design features and basic fundamental scientific technology
  • The same dimensions
  • The same device compatibility

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

glenohumeral joint (shoulder)

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)

This submission references cleaning and sterilization assessments conducted to demonstrate substantial equivalence of the modified Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap to the predicate Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap.

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.

Results of engineering studies referenced in this 510(k) submission demonstrate the modified Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap are substantially equivalent to the cited cleared Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K063569, K110708

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the 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

March 6, 2017

Exactech Inc Zach Sharrah Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K162325

Trade/Device Name: Exactech Equinoxe Reverse Shoulder Locking Cap. Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw 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: February 13, 2017 Received: February 14, 2017

Dear Zach Sharrah:

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) к162325

Device Name

Exactech® Equinoxe® Reverse Shoulder Compression Screws, Glenosphere Locking Cap

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Exactech® Equinoxe® Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap Special 510(k) - 510(k) Summary of Safety and Effectiveness

| Sponsor: | Exactech®, Inc
2320 NW 66th Court
Gainesville FL, 32653

Phone: (352) 377-1140
Fax: (352) 378-2617 |
|-------------------|-------------------------------------------------------------------------------------------------------------------|
| | FDA Establishment Number 1038671 |
| Contact Person: | Zach Sharrah
Regulatory Affairs Specialist
Telephone: (352) 327-4674
Fax: (352) 378-2617 |
| Date: | February 13, 2017 |
| Proprietary Name: | Exactech® Equinoxe® Reverse Shoulder Compression Screws,
Glenosphere Locking Screw, and Locking Cap |
| Common Name: | Reverse Shoulder Arthroplasty |

Classification Name:

  • Prosthesis, Shoulder, Non-Constrained, Metal/Polymer cemented (21 CFR ● Section 888.3650, Class II, Product Code KWT
  • . Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer cemented (21 CFR Section 888.3660, Class II, Product Code KWS
  • Shoulder Prosthesis, Reverse Configuration (21 CFR Section 888.3660, . Class II, Product Code PHX

Legally Marketed Device to Which Substantial Equivalence Is Claimed:

NameManufacturer510(k) Number
Equinoxe Reverse Shoulder SystemExactech, IncK063569
Equinoxe Reverse ShoulderExactech, IncK110708

Indication for Use:

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.

4

Exactech® Equinoxe® Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap Special 510(k) - 510(k) Summary of Safety and Effectiveness

Device Description:

The proposed Exactech Equinoxe Reverse Shoulder Compression Screws. Glenosphere Locking Screw, and Locking Cap devices represent a modification of the predicate Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap (K063569 and K110708) used in reverse shoulder arthroplasty. All devices were cleared via 510(k) K063569 except the 50mm and 54mm Equinoxe Reverse Shoulder Compression Screws. These sizes were cleared via 510(k) K110708. The only difference between the proposed Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap and predicate Equinoxe Compression Screws, Glenosphere Locking Screw, and Locking Cap is the sterilization method. The predicate compression screws, glenosphere locking screw, and locking cap are provided sterile via gamma radiation. The modified compression screws, glenosphere locking screw, and locking cap will be supplied non-sterile and must be sterilized by steam sterilization in a separately provided re-usable sterilization container prior to implantation. Cleaning and sterilization instructions are provided in the package insert for the Equinoxe Reverse Shoulder System Screw Components.

Both the predicate and modified devices share the following similarities:

  • The same indications for use ●
  • The same intended use ●
  • The same materials ●
  • The same design features and basic fundamental scientific technology
  • The same dimensions
  • The same device compatibility

Testing:

This submission references cleaning and sterilization assessments conducted to demonstrate substantial equivalence of the modified Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap to the predicate Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap.

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 modified Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap are substantially equivalent to the cited cleared Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap predicate devices.