(114 days)
Not Found
No
The document describes a mechanical shoulder prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, a hemi or total shoulder prosthesis, is intended for cemented use to treat severely painful and/or disabled shoulder joints resulting from various conditions like osteoarthritis, traumatic arthritis, rheumatoid arthritis, and fracture dislocations of the proximal humerus. Its purpose is to relieve pain and improve function, which aligns with the definition of a therapeutic device.
No
This device is a shoulder prosthesis, an implant used to replace or augment a damaged shoulder joint. It is a treatment device, not a diagnostic one.
No
The device description clearly details physical components made of titanium alloy, indicating it is a hardware device, not software-only.
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 SEVIIN Fracture Shoulder is a prosthesis intended for surgical implantation to replace or repair a damaged shoulder joint. It is a physical implant used within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing procedures.
Therefore, the SEVIIN Fracture Shoulder falls under the category of a surgical implant or prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Hemi or Total Shoulder:
The SEVIIN Fracture Shoulder is intended for cemented use for a severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. It is also intended for 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. The device can be used in other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of failed primary component). Hemi-shoulder replacement is also indicated for un-united humeral head fractures and avascular necrosis of the humeral head.
Reverse Shoulder:
The SEVIIN Fracture Shoulder is also indicated for fracture total shoulder arthroplasty (due to acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint) for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The SEVIIN Fracture Shoulder humeral stems are intended for cemented applications. The glenoid components are intended for cemented use (total shoulder arthroplasty) and the TPS coated metaglene component is intended for cementless use with the addition of screws for fixation (reverse arthroplasty).
Product codes (comma separated list FDA assigned to the subject device)
KWS, HSD, KWT
Device Description
The SEVIIN Fracture Shoulder is a hemi or total shoulder prosthesis designed for use in patients with acute fracture of the proximal humerus. The modularity of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder. Additionally, the SEVIIN Fracture Shoulder can be used with the SEVIIN Reverse shoulder for relief of pain or significant disability associated with a grossly deficient or non-repairable rotator cuff joint if necessary.
The Fracture Humeral Stems are manufactured from Ti-6Al-4V utanium alloy conforming to ASTM F136 and have a corundum blasted proximal surface to enhance bone cement fixation. Lateral fins with suture holes are designed for soft tissue attachment. The device features an anatomical neck/shaft angle and a 6 degree taper to mate with humeral heads (hemi or total shoulder) or a humeral cup (reverse shoulder).
Five sizes of fracture stems are available: 8, 10, 12mm diameter x 120mm and 8 and 10mm diameter x 200mm with a polished and fluted distal stem.
The Fracture humeral stems can be used with the SEVIIN Total Shoulder Humeral Heads and Glenoids (K043346) in addition to SEVIIN Reverse Shoulder components (K120374).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joint, proximal humerus, glenohumeral joint
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was based on a comparison of intended use, indications, materials, sizes and design. Non-clinical testing was not performed. Clinical testing was not necessary to demonstrate substantial equivalence of the SEVIIN Fracture Shoulder to the predicate 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.
Genesis Total Shoulder Replacement, K043346, DePuy Global Fx Humeral Stem, Global Advantage, K984541, Exactech Equinoxe Platform Fracture Stem, K092900, Ingen Seviin Reverse Shoulder, K120374
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
§ 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
ﺴﺴ
| 510(k) Summary | |
|---|---|
| Prepared: | April 26, 2013 |
| Submitter: | Ingen Orthopedics, LLC |
| 2650 US Highway 130 | |
| Cranbury, NJ 08512 | |
| Contact: | Perry A. Geremakis |
| President, Chief Executive Officer | |
| Ingen Orthopedics, LLC | |
| P: 609/409-3316 | |
| F: 609/409-3317 | |
| E: pgeramakis@ingenortho.com | |
| Proprietary Name: | SEVIIN Fracture Shoulder |
| Common Name: | Fracture Humeral Stem Shoulder Prosthesis |
| Classification Names: | 21 CFR 888.3660: Shoulder joint metal/polymer semi- |
| constrained cemented prosthesis; Class II | |
| 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) | |
| metallic uncemented prosthesis; Class II | |
| Product Codes: | KWS, HSD |
| Substantially | |
| Equivalent Devices: | Genesis Total Shoulder Replacement, K043346, cleared |
| Jan 31, 2005 | |
| DePuy Global Fx Humeral Stem, Global Advantage, | |
| K984541, cleared Jan 14, 1999. | |
| Exactech Equinoxe Platform Fracture Stem, K092900, | |
| cleared Jan 7, 2010. | |
| Ingen Seviin Reverse Shoulder, K120374, cleared July 9, |
- |
:
.
1
Device Description:
The SEVIIN Fracture Shoulder is a hemi or total shoulder prosthesis designed for use in patients with acute fracture of the proximal humerus. The modularity of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder. Additionally, the SEVIIN Fracture Shoulder can be used with the SEVIIN Reverse shoulder for relief of pain or significant disability associated with a grossly deficient or non-repairable rotator cuff joint if necessary.
The Fracture Humeral Stems are manufactured from Ti-6Al-4V utanium alloy conforming to ASTM F136 and have a corundum blasted proximal surface to enhance bone cement fixation. Lateral fins with suture holes are designed for soft tissue attachment. The device features an anatomical neck/shaft angle and a 6 degree taper to mate with humeral heads (hemi or total shoulder) or a humeral cup (reverse shoulder).
Five sizes of fracture stems are available: 8, 10, 12mm diameter x 120mm and 8 and 10mm diameter x 200mm with a polished and fluted distal stem.
The Fracture humeral stems can be used with the SEVIIN Total Shoulder Humeral Heads and Glenoids (K043346) in addition to SEVIIN Reverse Shoulder components (K120374).
Intended Use / Indications:
Hemi or Total Shoulder:
.
The SEVIIN Fracture Shoulder is intended for cemented use for a severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. It is also intended for 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. The device can be used in other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of failed primary component). Hemi-shoulder replacement is also indicated for un-united humeral head fractures and avascular necrosis of the humeral head.
Reverse Shoulder:
The SEVIIN Fracture Shoulder is also indicated for fracture total shoulder arthroplasty (due
8
2
to acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint) for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The SEVIIN Fracture Shoulder humeral stems are intended for cemented applications. The glenoid components are intended for cemented use (total shoulder arthroplasty) and the TPS coated metaglene component is intended for cementless use with the addition of screws for fixation (reverse arthroplasty).
Summary of Technologies / Substantial Equivalence:
The SEVIIN Fracture Shoulder is substantially cquivalent to the predicate devices in regards to its intended use and indications, materials, size ranges, and design intent. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues.
Non-Clinical Testing:
Substantial equivalence was based on a comparison of intended use, indications, materials, sizes and design. Non-clinical testing was not performed.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the SEVIIN Fracture Shoulder to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2013
Ingen Orthopedics, LLC Mr. Perry A. Geremakis President, Chief Executive Officer 2650 US Highway 130 Cranbury, New Jersey 08512
Re: K131277
Trade/Device Name: SEVIIN Fracture Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: KWS, HSD, KWT Dated: May 23, 2013 Received: May 30, 2013
Dear Mr. Geremakis:
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 If your device 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
4
Page 2 - Mr. Perry A. Geremakis
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/ReportalProblem/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,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K131277 510(k) Number (if known):
Device Name: SEVHN Fracture Shoulder
Indications for Use:
I lemi or Total Shoulder:
The SEVIIN Fracture Shoulder is intended for cemented use for a severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. It is also intended for 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. The device can be used in other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of failed primary component). Hemi-shoulder replacement is also indicated for un-united humeral head fractures and avascular necrosis of the humeral head.
Reverse Shoulder:
The SEVIIN Fracture Shoulder is also indicated for fracture total shoulder arthroplasty (due to acute fracture of the proximal humerus in combination with degenerative discases of the glenohumeral joint) for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The SEVIIN Fracture Shoulder humeral stems are intended for cemented applications. The glenoid components are intended for cemented use (total shoulder arthroplasty) and the TPS conted metaglene component is intended for cementless use with the addition of screws for fixation (reverse arthroplasty).
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW. THIS LINE-CONTINUE ON ANQUIHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
Page 1 of 1
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
G