(24 days)
No
The document describes a mechanical implant and its components, with no mention of AI or ML technologies. The rationale for the modification is purely mechanical (offset size).
Yes
The device is indicated to relieve pain and restore function in individuals with degenerative diseases of the glenohumeral joint and a deficient rotator cuff, directly addressing a health condition.
No
The device is a reverse shoulder system intended to relieve pain and restore function in individuals with degenerative shoulder conditions or failed previous replacements. It is a surgical implant, not a tool for identifying or characterizing a disease.
No
The device description clearly states it is a "Humeral Adapter Tray," which is a physical component of a shoulder implant system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to relieve pain and restore function in the shoulder joint by replacing it. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The device is a humeral adapter tray, a component of a shoulder replacement system. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant used in surgery.
N/A
Intended Use / Indications for Use
The Exactech® Equinoxe® Reverse Shoulder System is indicated to relieve pain and restore function 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 failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
Product codes
PHX, KWS, KWT
Device Description
The proposed Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray is a modification to the existing Equinoxe® Reverse Shoulder System humeral adapter tray devices previously cleared in K063569. The +15mm humeral adapter tray mates with previously cleared Equinoxe primary press-fit, primary cemented, and cemented revision/long humeral stems (K042021) and the Equinoxe reverse shoulder components (K063569). The rationale for the device line extension is to offer an additional size of offset to tension the deltoid and provide stability.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
- The same indications for use
- The same design features
- Incorporate the same materials
- The same shelf life
- Are packaged and sterilized using the same materials and processes.
The only modification to the predicate device consists of a proposed dimensional change to increase the thickness of the humeral adapter tray to provide a +15mm offset.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head, 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)
Results of engineering studies referenced in this 510(k) submission demonstrate that the Exactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray is substantially equivalent to the cleared predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized design featuring three human profiles facing right, layered on top of each other. The profiles are rendered in black and have a flowing, abstract quality. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Exactech, Incorporated Shing Jen Tai, PhD Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K082702
Trade/Device Name: Exactech® Equinoxe® Reverse Shoulder System +15 mm Humeral Adapter Tray Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWT Dated: September 12, 2008 Received: September 16, 2008
Dear Dr. Tai:
This letter corrects our substantially equivalent letter of October 10, 2008.
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. Ilsting 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
1
Page 2 - Shing Jen Tai, PhD
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 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® Reverse Shoulder System +15mm Humeral Adapter Tray Special 510(k) - Indications for Use
Indications for Use Statement
510(k) Number:
KO82702
Device Name: Exactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray
INDICATIONS FOR USE:
The Exactech® Equinoxe® Reverse Shoulder System is indicated to relieve pain and restore function 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 failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
Prescription Use X and/or (Part 21 CFR 801 Subpart D)
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)
(Division Division of Gene 31, Restorative, and Neurological Devices
-Section
Page 1 of 1 16082702
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Koranaa
Exactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tra Special 510(k) - 510(k) Summary of Safety and Effectiveness
OCT 1 0 2008
510(k) Summary of Safety and Effectiveness
Exactech® Inc. Sponsor: 2320 N.W. 66" Court Gainesville, FL 32653
Phone: (352) 377-1140 Fax: (352) 378-2617
FDA Establishment Number 1038671
Shing Jen Tai, PhD Contact: Regulatory Affairs Specialist
Date: September 12, 2008
Trade or Proprietary or Model Name(s):
Exactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray
Common Name:
Reverse Shoulder Prosthesis
Classification Name:
Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR 888.3650, Class II, Product Code KWT) Prosthesis, Shoulder, Semi-constrained, metal/polymer cemented (21 CFR 888.3660, Class II, Product Code KWS)
Information on devices to which Substantial equivalence is claimed:
| 510(k)
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K063569 | Equinoxe® Reverse Shoulder System | Exactech, Inc. |
4
Exactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Special 510(k) - 510(k) Summary of Safety and Effectiveness
dications for Use:
e Exactech® Equinoxe® Reverse Shoulder System is indicated to relieve pain and restore nction in skeletally mature individuals with degenerative diseases of the glenohumeral joint d a grossly deficient, irreparable rotator cuff. The Equinoxe® Reverse Shoulder is also dicated for failed glenohumeral joint replacement with loss of rotator cuff function resulting in uperior migration of the humeral head.
evice Description:
he proposed Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray is a nodification to the existing Equinoxe® Reverse Shoulder System humeral adapter tray devices eviously cleared in K063569. The +15mm humeral adapter tray mates with previously cleared Equinoxe primary press-fit, primary cemented, and cemented revision/long humeral stems (042021) and the Equinoxe reverse shoulder components (K063569). The rationale for the evice line extension is to offer an additional size of offset to tension the deltoid and provide tability.
e predicate and proposed devices have the same intended use and basic fundamental scientific hnology and share the following similarities:
- he same indications for use
- the same design features
- incorporate the same materials
- the same shelf life
- are packaged and sterilized using the same materials and processes.
only modification to the predicate device consists of a proposed dimensional change to crease the thickness of the humeral adapter tray to provide a +15mm offset.
ostantial Equivalence Conclusion:
esults of engineering studies referenced in this 510(k) submission demonstrate that the ixactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray is substantially quivalent to the cleared predicate devices.