K Number

Device Name

EQUINOXE EXTRA SHORT HUMERAL HEAD

Manufacturer

EXACTECH, INC.

Date Cleared

2014-02-11

(32 days)

Product Code

KWS

Regulation Number

888.3660

Intended 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 hemiarthroplasty is determined by the surgeon to be the preferred method of treatment. The cemented primary humeral stem, long/revision stem, fracture 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 wellfixed/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: 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 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 mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemiarthroplasty), 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.

Device Description

The proposed Equinoxe extra short humeral heads represent a modification to Equinoxe short humeral heads cleared per 510(k) K042021. Both predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The only differences between predicate and proposed devices are the following dimensional modifications: 1) Proposed device thickness is decreased by 3mm. 2) Proposed device female taper length is reduced by 5mm. 3) Proposed device female taper length is offset, where only 44mm and 47mm predicate devices feature offset female taper lengths. These modifications are proposed to provide surgeons with additional options for matching variation in patient anatomical needs.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K042021

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical orthopedic implant with dimensional modifications, and there is no mention of AI or ML technology in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is a shoulder system used for the surgical treatment of degenerative diseases and fractures of the glenohumeral joint, and its intended uses and clinical indications describe its role in addressing these medical conditions.

Diagnostic

No
The device is a component of a shoulder replacement system (Equinoxe Shoulder System) used for surgical treatment, not for diagnosing a condition. Its intended use is to replace or reconstruct portions of the glenohumeral joint in skeletally mature individuals with degenerative diseases or fractures.

SaMD (Software as a Medical Device)

The device description clearly states it is a modification to physical humeral heads, which are hardware components used in shoulder arthroplasty. The performance studies also involve physical testing (cyclic fatigue, axial pull-off, cadaveric validation).

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The description clearly states that the Equinoxe Shoulder System is a surgical implant used to replace or repair the glenohumeral joint (shoulder joint) in skeletally mature individuals with degenerative diseases or fractures. It is a physical device implanted into the body.
No Mention of Samples or Testing: The text does not mention any analysis of biological samples or diagnostic testing.

Therefore, the Equinoxe Shoulder System is a surgical implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The cemented primary humeral stem. long/revision stem, fracture 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 wellfixed/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
√	√		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 mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemiarthroplasty), 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)

KWS

Device Description

1. Proposed device thickness is decreased by 3mm.
1. Proposed device female taper length is reduced by 5mm.
1. Proposed device female taper length is offset, where only 44mm and 47mm predicate devices feature offset female taper lengths.

These modifications are proposed to provide surgeons with additional options for matching variation in patient anatomical needs.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

glenohumeral joint, humeral head, mid-humerus

Indicated Patient Age Range

skeletally mature

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)

The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed Equinoxe extra short humeral heads to the predicate Equinoxe short humeral heads:

Cyclic fatigue testing .
. Axial pull-off testing
Surgical evaluation/cadaveric validation .

Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Equinoxe extra short humeral heads are substantially equivalent to cleared predicate Equinoxe short humeral head 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

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

Regulation Number and Section

§ 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.”

Summary

Exactech® Equinoxe® Extra Short Humeral Heads Special 510(k) - 510(k) Summary of Safety and Effectiveness

FEB 1 1 2014

Sponsor: Exactech. Inc. 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 327-4762 Fax: (352) 378-2617

FDA Establishment Number 1038671

Contact: Patrick Hughes Senior Regulatory Affairs Specialist
January 9. 2014 Date:

Trade of Proprietary or Model Name(s): Exactech® Equinoxe® Extra Short Humeral Heads

Common Name:

Total Shoulder Arthroplasty - Humeral Components

Classification Name:

Prosthesis, shoulder, semi-constrained, metal/polymer cemented (CFR 888.3660, Shoulder joint metal/polymer semi-constrained cemented prosthesis Class II, Product Code KWS)

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or Proprietary Model Name	Manufacturer
K042021	Equinoxe Shoulder System	Exactech, Inc

Indications for Use:

The cemented primary humeral stem. long/revision stem, fracture 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 wellfixed/stable, as deemed by the orthopaedic surgeon.
Humeral Heads are intended for use in cemented and press-fit applications. .

Exactech® Equinoxe® Extra Short Humeral Heads Special 510(k) - 510(k) Summary of Safety and Effectiveness

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)

Exactech® Equinoxe® Extra Short Humeral Heads Special 510(k) - 510(k) Summary of Safety and Effectiveness

Device Description:

1. Proposed device thickness is decreased by 3mm.
1. Proposed device female taper length is reduced by 5mm.
1. Proposed device female taper length is offset, where only 44mm and 47mm predicate devices feature offset female taper lengths.

These modifications are proposed to provide surgeons with additional options for matching variation in patient anatomical needs.

Testing:

The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed Equinoxe extra short humeral heads to the predicate Equinoxe short humeral heads:

Cyclic fatigue testing .
. Axial pull-off testing
Surgical evaluation/cadaveric validation .

Substantial Equivalence Conclusion:

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 11, 2014

Exactech, Inc. Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653

Re: K140063

Trade/Device Name: Exactech® Equinoxe® Extra Short Humeral Heads Regulation Number: 21 CFR 888,3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: January 9, 2014 Received: January 13, 2014

Dear Mr. Hughes:

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

Page 2 - Mr. Patrick Hughes

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wigqins

for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Exactech® Equinoxe® Extra Short Humeral Heads Special 510(k) - Indications for Use

510(k) Number: _K140063

Device Name: Exactech® Equinoxe® Extra Short Humeral Heads

INDICATIONS

The cemented primary humeral stem, long/revision stem, fracture 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 wellfixed/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
√	√		To restore mobility from previous procedures (e.g. previous fusion)

Exactech® Equinoxe® Extra Short Humeral Heads Special 510(k) - Indications for Use

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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices