(194 days)
No
The document describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a joint replacement system indicated for use in treating various conditions causing severe pain, disability, or fractures of the shoulder, which directly aims to restore function and alleviate symptoms.
No
Explanation: The device is an orthopedic implant (shoulder replacement system) used for treatment, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of materials like cobalt-chrome-molybdenum and ultra high molecular weight polyethylene, indicating it is a hardware device (a shoulder replacement system).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The description clearly states that the Ascension Modular Total Shoulder System is a surgical implant used for replacing a joint in the shoulder. It is a physical device implanted into the body to restore function and alleviate pain.
- Lack of Specimen Examination: There is no mention of this device being used to examine any biological specimens outside of the body. Its function is entirely within the body as a prosthetic joint.
Therefore, the Ascension Modular Total Shoulder System falls under the category of a surgical implant/prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
-
- Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component).
Shoulder Hemiarthroplasty is also indicated for:
-
- Ununited humeral head fractures.
-
- Avascular necrosis of the humeral head.
-
- Rotator cuff arthropathy.
-
- Deformity and/or limited motion.
The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.
Product codes
HSD, KWS
Device Description
The Modular Total Shoulder System consists of a line of proximal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural numeral nead may befficient bearing surface, or in conjunction with the glenoid, as a gronold proximal bodies and humeral stems are manufactured from total replacemont: "The and connect together via a Morse type taper. The humeral theads are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and are offered in both concentric and eccentric configurations. The humeral head may onered in both contral glenoid bone if it is of sufficient quality, or against the all antionate against the naturanid. The glenoid is manufactured from ultra high polycthylone oomonton gronone (UHMVPE) and is offered in a keeled and pegged molecular weight porychylons (Ornaare designed to function with both the concentric and eccentric heads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Substantial equivalence was based upon testing and a geometrical comparison of the subject and predicate devices. Tests performed to substantiate equivalence were: axial disassembly force of taper connections, bending taper fatigue endurance, and dynamic evaluation of glenoid loosening.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary
| SUBMITTER NAME: | Ascension Orthopedics, Inc.
8700 Cameron Road
Austin, TX 78754-3832 | AUG 30 2010 |
|-----------------|------------------------------------------------------------------------------------------|-------------|
| 510(k) CONTACT: | Stanley J. Harris
Phone: (512) 836-5001 x1545 | |
| DATE: | August 26, 2010 | |
| TRADE NAME: | Ascension® Modular Total Shoulder System | |
| COMMON NAME: | Hemi- or Total shoulder | |
| CLASSIFICATION: | 21 CFR 888.3690 Shoulder joint humeral (hemi-shoulder)
metallic uncemented prosthesis | |
| | 21 CFR 888.3660, Shoulder joint metal/polymer semi-
constrained cemented prosthesis | |
| PRODUCT CODE: | HSD and KWS | |
| PANEL: | Orthopedic | |
PREDICATE DEVICES:
K032126/K063578 - Smith & Nephew/Plus Orthopedics PROMOS Modular Shoulder System
K962082: Osteonics' All Polyethylene Glenoid Shoulder Keeled Components
DEVICE DESCRIPTION:
The Modular Total Shoulder System consists of a line of proximal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural numeral nead may befficient bearing surface, or in conjunction with the glenoid, as a gronold proximal bodies and humeral stems are manufactured from total replacemont: "The and connect together via a Morse type taper. The humeral theads are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and are offered in both concentric and eccentric configurations. The humeral head may onered in both contral glenoid bone if it is of sufficient quality, or against the all antionate against the naturanid. The glenoid is manufactured from ultra high polycthylone oomonton gronone (UHMVPE) and is offered in a keeled and pegged molecular weight porychylons (Ornaare designed to function with both the concentric and eccentric heads.
1
INTENDED USE:
The Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
-
- Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component).
Shoulder Hemiarthroplasty is also indicated for:
-
- Ununited humeral head fractures.
-
- Avascular necrosis of the humeral head.
-
- Rotator cuff arthropathy.
-
- Deformity and/or limited motion.
The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.
SUMMARY OF TECHNOLOGIES:
There are no significant differences between the Ascension® Modular Total Shoulder System, to the Smith & Nephew/Plus Orthopedics PROMOS Modular Shoulder System (K032126/K063578) currently being marketed which would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and intended use.
SUBSTANTIAL EQUIVALENCE:
Substantial equivalence was based upon testing and a geometrical comparison of the subject and predicate devices. Tests performed to substantiate equivalence were: axial disassembly force of taper connections, bending taper fatigue endurance, and dynamic evaluation of glenoid loosening. Geometrical comparisons were between the subject device, Ascension TITAN Modular Total Shoulder System and predicate devices: Smith & Nephew/PLUS PROMOS Modular Shoulder System (K032126, uons578) and the Osteonics' All Polyethylene Glenoid Shoulder Keeled Components (K962082).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a stylized serpent winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ascension Orthopedics, Inc. % Mr. Stanley J. Harris Vice President, Clinical/Regulatory Affairs 8700 Cameron Road, Suite 100 Austin, Texas 78754
AUG 30 2010
Re: K100448
Trade/Device Name: Ascencion® Modular Total Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS. HSD Dated: August 10, 2010 Received: August 17, 2010
Dear Mr. Harris:
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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Stanley J. Harris
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Carbare Buere
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K100448 510(k) Number.
Ascension® Modular Total Shoulder System Device Name:
Indications for Use:
The Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
-
- Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component).
Shoulder Hemiarthroplasty is also indicated for:
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component).
-
- Ununited humeral head fractures.
-
- Avascular necrosis of the humeral head.
-
- Rotator cuff arthropathy.
-
- Deformity and/or limited motion.
The humeral component is intended for cemented or un-cemented use. The glenoid component is intended for cemented use only.
Prescription Use x (Part 21 CFR 801Subpart B)
Over-The-Counter Use OR (Part 21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Knutar der Mom
(Division Sign-(Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number KJ 00448
8