(231 days)
Not Found
No
The summary describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is a total shoulder system intended for use as a joint replacement, which is a therapeutic intervention for painful and/or disabled joints.
No
Explanation: This device is a total shoulder replacement system, which is a therapeutic device intended to replace a damaged joint, not diagnose a condition.
No
The device description clearly outlines physical components (metaphyseal bodies, humeral stems, humeral heads, glenoid components) which are hardware implants for shoulder replacement surgery.
Based on the provided information, 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, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The Ascension TITAN Total Shoulder System is a surgical implant designed to replace parts of the shoulder joint. It is used within the body during a surgical procedure.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose based on in vitro analysis.
Therefore, the Ascension TITAN Total Shoulder System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint.
The Ascension TITAN™ 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 indicated that alternativce 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 un-cemented use. The glenoid component is intended for cemented use only.
Product codes
HSD, KWS
Device Description
The TITAN Modular Total Shoulder System consists of a line of metaphyseal 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 glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The metaphyseal bodies and humeral stems are shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally-filling shape are designed to accommodate the natural humeral geometry and provide stable fixation, proximal bone loading and proper head placement. The humeral heads are offered with both concentric and eccentric articulating surfaces. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the all polyethylene cemented glenoid. The glenoid has two options: keeled or standard pegged (3 pegs). All glenoid options are designed to function with both the concentric and eccentric heads. The humeral components are intended for cemented or uncemented use, while the glenoid component is for use with cement only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, proximal humerus
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
Testing to support the material change and additional lengths for the humeral stems has been completed. The testing conforms to ASTM F1378.
Clinical performance data are not required for the minor changes that are the subject of this Special 510(k).
Key Metrics
Not Found
Predicate Device(s)
K100448 – Ascension® TITAN™ Total Shoulder System
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
| | | 2438 ( | | 2 )
APR 1 1 2012
510(k) Summary
:
·
:
.
| Sponsor | Ascension Orthopedics, Inc.
8700 Cameron Road
Austin, TX 78754-3832 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Susan Walton
susan.walton@integralife.com
Phone: (512) 836-5001 x1591
Alternate FAX (512) 836-6933 |
| Date | March 22, 2012 |
| Trade Name | Ascension® TITAN™ Total Shoulder System |
| Common Name | Hemi- or Total Shoulder |
| Classification | 21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained
cemented prosthesis
21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder)
metallic uncemented prosthesis. |
| Product Code | HSD and KWS |
| Panel | Orthopedic |
| Predicate Device | K100448 – Ascension® TITAN™ Total Shoulder System |
| Device Description | The TITAN Modular Total Shoulder System consists of a line of
metaphyseal 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 glenoid provides a sufficient bearing surface, or in
conjunction with the glenoid, as a total replacement. The
metaphyseal bodies and humeral stems are shaped to provide
proximal fixation and optimal fixation area. Their variable length
and proximally-filling shape are designed to accommodate the
natural humeral geometry and provide stable fixation, proximal
bone loading and proper head placement. The humeral heads are
offered with both concentric and eccentric articulating surfaces. The
humeral head may articulate against the natural glenoid bone, if it is
of sufficient quality, or against the all polyethylene cemented
glenoid. The glenoid has two options: keeled or standard pegged (3
pegs). All glenoid options are designed to function with both the
concentric and eccentric heads.
The humeral components are intended for cemented or uncemented
use, while the glenoid component is for use with cement only. |
| Intended Use | A shoulder joint metal/polymer semi-constrained cemented
prosthesis is a device intended to be implanted to replace a shoulder
joint. |
| Intended Use | The Ascension TITAN™ Total Shoulder System is indicated for
use as a hemi or total shoulder replacement for: |
1
-
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 indicated that alternativce 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 un-cemented use. The glenoid component is intended for cemented use only.
Ascension Orthopedics believes that this system is substantially equivalent to the legally marketed predicate device based on similarities in design, materials and indications.
Testing to support the material change and additional lengths for the humeral stems has been completed. The testing conforms to ASTM F1378.
Clinical performance data are not required for the minor changes that are the subject of this Special 510(k).
Basis of Substantial Equivalence
Non-clinical Performance Data
Clinical Performance Data
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ascension Orthopaedics, Incorporated % Ms. Susan Walton Senior Director of Regulatory Affairs 8700 Cameron Road Austin, Texas 78754
APR 1 1 2012
Re: K112438
Trade/Device Name: Ascension® TITANTM Total Shoulder System 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: March 22, 2012 Received: March 23, 2012
Dear Ms. Walton:
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 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.
3
Page 2 - Ms. Susan Walton
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Molkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
112438 (11)
Indications for Use Statement
510(K) Number:
Ascension® TITAN™ Total Shoulder System Device Name:
Indications for Use:
The Ascension TITAN 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 indicated 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. s
The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.
OR
Prescription Use __ x (Part 21 CFR 801Subpart B)
Over-The-Counter Use (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)
Ro. Oulil
(Division Sign Off)
Division Sign-Off) ivision of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112438