(35 days)
Not Found
Not Found
No
The device description focuses on the mechanical components and materials of a humeral stem and head prosthesis. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended for the treatment of various shoulder joint conditions, including arthritis and omarthrosis, by replacing the proximal portion of the humerus. This directly addresses health issues to restore function.
No
The device description indicates it is an implantable humeral stem and head, used for replacement of the proximal portion of the humerus. This is a therapeutic device, not a diagnostic one.
No
The device description clearly details physical components made of metallic alloys (stainless steel, CoCrMo) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
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 used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Anatomica Humeral Stem/Head is a prosthetic implant intended for surgical replacement of the proximal portion of the humerus (a bone in the arm).
- Intended Use: The intended uses are all related to treating conditions affecting the shoulder joint through surgical intervention and implantation, not through laboratory testing of samples.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Anatomica Humeral Stem/Head is intended for cemented use in treatment of the following:
- Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
- Omarthrosis.
- Rheumatoid arthritis.
- Revision of shoulder prosthesis.
- Traumatology: the only cone to be used in traumatological indications is the traumatology cone.
Product codes (comma separated list FDA assigned to the subject device)
KMS
Device Description
The Anatomica Humeral Stem Component is intended for replacement of the proximal portion of the humerus.
The Anatomica Humeral Stem is a metallic humeral component manufactured from forged stainless steel alloy (ISO 5832-9). It is available in four sizes which are determined by the diameter of the stem. The proximal aspect of the stem is "trumpet shaped" to match the metaphysis of the humeral shaft. Rotational stability is ensured by a proximal fin on the lateral Two holes in the fin and one in the medial stem body allow for attachment of the aspect. tuberosities via sutures/wires.
The stem features a slit-ball head fixed at an angle of 135°. An impact screw and expansion cone are inserted through a shaft in the lateral aspect of the stern and into the slit-ball head at the time of surgery. This forces the slit-ball feature to spread open allowing fixation of one of the humeral heads used with the system. The use of the slit ball has the advantage of allowing fixation of the head in a variety of angles. A traumatology cone identical to the expansion cone, except with positioning pegs for head placement, is also available.
Humeral Heads
The heads are manufactured from cast CoCrMo alloy (ISO 5832-4). They are available in 10 sizes with diameters ranging from 40-52mm (in 2mm increments). Sizes 48, 50 and 52mm are offered in two head heights. The spherical female recess for attachment to the slit-ball head of the stem is situated eccentrically to the radius of the humeral head. This recess also features two internal holes for defining position in fracture cases (used in conjunction with the traumatology cone).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Static and Dynamic Testing indicated that the device would survive physiologic loading.
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.
Not Found
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
2/18/99
510(k) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics Anatomica Humeral Stem/Heads.
| Manufacturer: | Sulzer Orthopedics Ltd.
Grabenstrasse 25
CH 6341 Baar, Switzerland |
|-------------------------|-----------------------------------------------------------------------------------------|
| US Designated Agent: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
| Date: | January 15, 1998 |
| Contact Person: | Mitchell A. Dhority, RAC
Manager, Regulatory Affairs |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented
prosthesis - 21 CFR 888.3660 |
| Common/Usual Name: | Humeral Stem and Head Components |
| Trade/Proprietary Name: | Sulzer Orthopedics Anatomica Humeral Stem/Head |
PRODUCT DESCRIPTION
Humeral Stem
The Anatomica Humeral Stem Component is intended for replacement of the proximal portion of the humerus.
The Anatomica Humeral Stem is a metallic humeral component manufactured from forged stainless steel alloy (ISO 5832-9). It is available in four sizes which are determined by the diameter of the stem. The proximal aspect of the stem is "trumpet shaped" to match the metaphysis of the humeral shaft. Rotational stability is ensured by a proximal fin on the lateral Two holes in the fin and one in the medial stem body allow for attachment of the aspect. tuberosities via sutures/wires.
The stem features a slit-ball head fixed at an angle of 135°. An impact screw and expansion cone are inserted through a shaft in the lateral aspect of the stern and into the slit-ball head at the time of surgery. This forces the slit-ball feature to spread open allowing fixation of one of the humeral heads used with the system. The use of the slit ball has the advantage of allowing fixation of the head in a variety of angles. A traumatology cone identical to the expansion cone, except with positioning pegs for head placement, is also available.
Humeral Heads
The heads are manufactured from cast CoCrMo alloy (ISO 5832-4). They are available in 10
1
sizes with diameters ranging from 40-52mm (in 2mm increments). Sizes 48, 50 and 52mm are offered in two head heights. The spherical female recess for attachment to the slit-ball head of the stem is situated eccentrically to the radius of the humeral head. This recess also features two internal holes for defining position in fracture cases (used in conjunction with the traumatology cone).
SPECIFIC DIAGNOSTIC INDICATIONS
The Anatomica Humeral Stem/Head is intended for cemented use in treatment of the following:
-
- Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
-
- Omarthrosis.
-
- Rheumatoid arthritis.
- Revision of shoulder prosthesis. 4.
-
- Traumatology: the only cone to be used in traumatological indications is the traumatology cone.
SUBSTANTIAL EQUIVALENCE
The Anatomica Humeral Prosthesis is similar to the Sulzer Orthopedics Select Shoulder Titanium Humeral Prosthesis, the Sulzer Orthopedics Select Shoulder CoCr Humeral Stem Prosthesis, the Orthomet/3M Modular Neer II Shoulder System, the Zimmer Fenlin Total Shoulder, the Smith & Nephew Richards Cofield Shoulder, the Kirschner/Biomet Atlas Shoulder, the Kirschner/Biomet Mod II-C Shoulder, the Biomet Bio-Modular Total Shoulder, and the Depuv Global Total Shoulder System.
Static and Dynamic Testing indicated that the device would survive physiologic loading.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles that are connected to each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1999
Mr. Mitchell A. Dhority Manager, Regulatory and Clinical Affairs Sulzer Orthopedics Inc. 9900 Spectrum Drive Austin, Texas 78717
K990137 Re: Anatomica Humeral Stem/Head Components Trade Name: Regulatory Class: III KMS Product Code: January 12, 1999 Dated: Received: January 14, 1999
Dear Mr. Dhority:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory 1 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
3
Page 2 - Mr. Mitchell A. Dhority
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 510(k) Number (if known): | K990137 |
|---|---|
| --------------------------- | --------- |
Device Name: Anatomica Humeral Stem/Heads
Indications for Use:
The Anatomica Humeral Stem/Head is intended for cemented use in treatment of the following:
and the control of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contrib
- Advanced wear and tear of the shoulder joint resulting from degenerative, 1. posttraumatic or rheumatoid arthritis.
- Omarthrosis. 2.
-
- Rheumatoid arthritis.
- Revision of shoulder prosthesis. 4.
- Traumatology: the only cone to be used in traumatological indications is the 5. traumatology cone.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K990137 |
Prescription Use
OR
Over-the Counter Use
(Optional Format 1-2-96)