(26 days)
No
The document describes a mechanical implant (shoulder stem) and its material properties and design. There is no mention of software, algorithms, or any technology that would suggest AI/ML is involved in its function or use.
Yes
The device is indicated for replacement in conditions causing severe pain or significant disability due to disease or injury of the glenohumeral joint, and other difficult clinical management problems, which are therapeutic functions.
No
Explanation: The device is an orthopedic implant (a modular stem) used for joint replacement, not for diagnosing medical conditions.
No
The device description explicitly states the device is a "modular stem" machined of "titanium alloy" with a "distal section," "proximal section," and "morse-taper," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant – a stem for a shoulder replacement (glenohumeral joint). It is a physical device implanted into the body.
- Intended Use: The intended use is to replace a damaged glenohumeral joint due to various conditions. This is a surgical procedure, not a diagnostic test performed on a sample.
The description clearly indicates this is a device used in the body for treatment, not a device used on samples outside the body for diagnosis.
N/A
Intended Use / Indications for Use
The Arthrex Univers Apex is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.
Product codes
KWS, HSD
Device Description
The Arthrex Univers Apex, Size 5 Stem, subject to this submission, is a smaller version of the previously cleared Arthrex Univers Apex (K131633). It is a modular stem with fixed inclination angle design and is the identical size as the previously cleared Size 5 Univers II stems (K103466). The stem is machined of titanium alloy. The distal section of the stem has a conical design. The proximal section of the stem is rectangular in design and has a morse-taper for the mating of humeral heads. The stem's surface finish is textured for cemented or press-fit (non-cemented) implantation. The Arthrex Univers Apex, Size 5 Stem falls within the length range of the previously cleared Univers Apex stems (K131633).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint; humeral head
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
The submitted mechanical testing data demonstrated that the performance of the proposed devices is substantially equivalent to that of the predicate devices. The mechanical data indicate that the Arthrex Univers Apex, Size 5 Stem is adequate for their intended use. Clinical data and conclusions are not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
K131633: Arthrex Univers Apex Stems, K103466: Arthrex Size 5 Univers II Stems
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 23, 2015
Arthrex, Incorporated Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K153115
Trade/Device Name: Arthrex Univers Apex, Size 5 Stem Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: October 26, 2015 Received: October 28, 2015
Dear Ms. Smith:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
Image /page/2/Picture/1 description: The image shows the Arthrex logo followed by the text "SPECIAL 510(K): ARTHREX UNIVERS APEX, SIZE 5 STEM". The Arthrex logo is a stylized "Arthrex" with a graphic of a surgical tool. The text indicates that the product is a special device that has been cleared by the FDA under section 510(k) of the Food, Drug, and Cosmetic Act. The product is the Arthrex Univers Apex, which is a size 5 stem.
2.5 INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Device Name
510(k) Number (if known)
Arthrex Univers Apex, Size 5 Stem
Indications for Use (Describe)
The Arthrex Univers Apex, Size 5 Stem is indicated for:
The Arthrex Univers Apex is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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O SPECIAL 510(K): ARTHREX UNIVERS APEX, SIZE 5 STEM
| Labels | Values |
|---|---|
| Date Summary Prepared | October 22, 2015 |
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Courtney SmithManager, Regulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext.71720Fax: 239/598.5508Email: Courtney.Smith@Arthrex.com |
| Trade Name | Arthrex Univers Apex, Size 5 Stem |
| Common Name | Shoulder Prosthesis |
| Product Code, Classification Name, CFR | KWS – Prosthesis, Shoulder, semi-constrained metal/polymer, cemented, CFR 888.3660HSD - Prosthesis, Shoulder, Hemi-Humeral, Metal, Uncemented, CFR 888.3690 |
| Predicate Device | K131633: Arthrex Univers Apex StemsK103466: Arthrex Size 5 Univers II Stems |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain clearance for a line extension to the Arthrex Univers Apex Stems. |
| Device Description | The Arthrex Univers Apex, Size 5 Stem, subject to this submission, is a smallerversion of the previously cleared Arthrex Univers Apex (K131633). It is a modularstem with fixed inclination angle design and is the identical size as the previouslycleared Size 5 Univers II stems (K103466). The stem is machined of titanium alloy.The distal section of the stem has a conical design. The proximal section of thestem is rectangular in design and has a morse-taper for the mating of humeralheads. The stem's surface finish is textured for cemented or press-fit (non-cemented) implantation. The Arthrex Univers Apex, Size 5 Stem falls within thelength range of the previously cleared Univers Apex stems (K131633). |
| Intended Use | The Arthrex Univers Apex is indicated in replacements(s) when conditions includesevere pain or significant disability resulting from degenerative, rheumatoid,traumatic disease, or injury of the glenohumeral joint; non-union humeral headfractures of long duration; irreducible 2- and 4- part proximal humeral fractures;avascular necrosis of the humeral head; or, other difficult clinical managementproblems where arthrodesis or resectional arthroplasty is not acceptable.The glenoid components are designed for cemented fixation in the joint and mustonly be used with an appropriate bone cement. |
| Substantial | The Arthrex Univers Apex, Size 5 Stem is substantially equivalent to the predicate |
2.6 510K SUMMARY OF SAFETY AND EFFECTIVENESS
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Arthrex Special 510(K): ARTHREX UNIVERS APEX, SIZE 5 STEM
| Equivalence Summary | devices in which the basic design features and intended uses are the same. An differences between the Arthrex Univers Apex, Size 5 Stem and the predicates are considered minor and do not raise questions concerning safety and effectiveness. |
|---|---|
| The proposed devices are substantially equivalent to the predicate devices in regards to its intended use, design, size range, and material. The submitted in vitro testing (cyclic compression loading) The submitted mechanical testing data demonstrated that the performance of the proposed devices is substantially equivalent to that of the predicate devices. The mechanical data indicate that the Arthrex Univers Apex, Size 5 Stem is adequate for their intended use. Clinical data and conclusions are not needed for this device. | |
| Based on the indication for use, technological characteristics, and the comparison to the predicate device, Arthrex, Inc. has determined that the Arthrex Univers Apex, Size 5 Stem is substantially equivalent to currently marketed predicate devices. |