(182 days)
No
The device description focuses on the mechanical components and materials of a shoulder implant, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.
Yes
The PROMOS® Shoulder is designed to restore shoulder motion and eliminate pain due to various conditions like arthritis, fractures, and avascular necrosis, which directly addresses medical conditions and improves health.
No
The PROMOS® Shoulder is an orthopedic implant designed to restore shoulder motion and eliminate pain in patients with various shoulder joint conditions. It is a treatment device, not a diagnostic one, as it does not diagnose medical conditions.
No
The device description clearly details physical components made of materials like UHMWPe, titanium alloy, and CoCrMo alloy, indicating it is a hardware medical device (a shoulder implant).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing components of the shoulder joint due to various conditions like arthritis, fractures, and necrosis. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a shoulder prosthesis (glenoid and humeral components) made from materials like polyethylene, titanium alloy, and CoCrMo alloy. These are materials used in surgical implants, not for in vitro diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition outside of the body.
In summary, the PROMOS® Shoulder is a surgical implant designed to restore function and reduce pain in the shoulder joint, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PROMOS® Shoulder is indicated for:
- Advanced wear of the shoulder joint due to degenerative, post-traumatic or rheumatoid arthritis.
- Fracture or avascular necrosis of the humeral head.
- Post-traumatic loss of joint configuration, especially in the case of functional impairment.
- Humerus fracture.
The humeral component is intended for cemented or cementless use.
The glenoid component is for use with bone cement only.
Product codes
HSD, KWS
Device Description
The PROMOS® Shoulder will help in restoring shoulder motion and eliminating pain.
The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe). The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components.
The humeral component is modular with a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross sectional shape and available in seven cementless sizes. It is attached to the body via a Morse type taper. Both cemented and cementless stems are fabricated from titanium alloy (Ti6Al4V) that conforms to ISO 5832-3. The body is made of titanium alloy and is available in three sizes. The body has a cavity in the proximal portion to accept the inclination set. The inclination set consists of an insert, offset module and ball screw. The ball screw inserts through the offset module and insert, and the assembly is threaded into the cavity in the body. The offset module can be set at various positions and when the ball screw is tightened into the body the offset module is locked into place. The offset module has a male Morse type taper to which the humeral head is attached. All components of the inclination set are made from titanium alloy. The offset module is available in three different heights resulting in the humeral head being placed at three heights.
The modular humeral heads are manufactured from CoCrMo alloy that conforms to ISO 5832-12. The head is available in eight different sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder 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)
The results of laboratory testing indicate that the PROMOS Shoulder will survive the expected in-vivo loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K010124, K990136, K990137, K003801, K003832
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
JAN - 8 2004
: :
510(k) Summary
NE 1 8
Date July 9, 2003
Submitter PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name Hemi- or total shoulder
Classification name
Prosthesis, shoulder, hemi-, humeral, metallic, uncemented, per 21 CFR Sec. 888.3690 or Prosthesis, shoulder, semi-constrained, metal/polymer, cemented, per 21 CFR Sec. 888.3660
Device Description
The PROMOS® Shoulder will help in restoring shoulder motion and eliminating pain.
The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe). The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components.
The humeral component is modular with a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross sectional shape and available in seven cementless sizes. It is attached to the body via a Morse type taper. Both cemented and cementless stems are fabricated from titanium alloy (Ti6Al4V) that conforms to ISO 5832-3. The body is made of titanium alloy and is available in three sizes. The body has a cavity in the proximal portion to accept the inclination set. The inclination set consists of an insert, offset module and ball screw. The ball screw inserts through the offset module and insert, and the assembly is threaded into the cavity in the body. The offset module can be set at various positions and when the ball screw is tightened into the body the offset module is locked into place. The offset module has a male Morse type taper to which the humeral head is attached. All components of the inclination set are made from titanium alloy. The offset module is available in three different heights resulting in the humeral head being placed at three heights.
The modular humeral heads are manufactured from CoCrMo alloy that conforms to ISO 5832-12. The head is available in eight different sizes.
Intended Use
The PROMOS Shoulder is indicated for:
- Advanced wear of the shoulder joint due to degenerative, post-traumatic or rheumatoid arthritis .
- Fracture or avascular necrosis of the humeral head ◆
- . Post-traumatic loss of joint configuration, especially in the case of functional impairment
- . Humerus fracture
- The humeral component is intended for cemented or cementless use.
The glenoid component is for use with bone cement only.
Summary of Technological Characteristics Compared to Predicate Device
The PROMOS Shoulder is similar to the Arthrex ( Arthrex, Inc , Naples, F L; K 010124) and Anatomical ( Sulzer Orthopedics, Inc.; Austin, TX; K990136, K990137, K003801, K003832) Shoulders in terms of material, adjustable inclination of humeral head, and indications for use.
Summary Non-clinical Tests
The results of laboratory testing indicate that the PROMOS Shoulder will survive the expected in-vivo loading.
1
Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 2004
PLUS Orthopedics C/o Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K032126 Trade/Device Name: PROMOS® Shoulder Regulation Numbers: 21 CFR 888.3690 and 21 CFR 888.3660 Regulation Names: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis and Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: HSD and KWS
Dated: October 7, 2003 Received: October 10, 2003
Dear Mr. Webb:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard nent date of the Medical Device Amendments, or to conniner co price to rile) 2008 in accordance with the provisions of the Federal Food, Drug, de vices that have been receasined in quire approval of a premarket approval application (PMA). and Cosmeter rece (110) that to neviee, subject to the general controls provisions of the Act. The 1 ou may, mercerere, mains 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be subject to have adoral 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 I teast of activisou that 1 1911 bilsean that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any i edital other since the regulements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC Fat 6077, laocing (2 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty byevisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. J.D. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis iction will and w your le FDA finding of substantial equivalence of your device to a legally prematicated 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), please in you don't be Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Millhamson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Koszizó 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PROMOS® Shoulder_
Indications for Use:
PROMOS® Shoulder Indications for Use
The PROMOS® Shoulder is indicated for:
- Advanced wear of the shoulder joint due to degenerative, post-traumatic or . rheumatoid arthritis
- Fracture or avascular necrosis of the humeral head .
- Post-traumatic loss of joint configuration, especially in the case of functional . impairment
- Humerus fracture �
The humeral component is intended for cemented or cementless use.
The glenoid component is for use with bone cement only.
(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, Neurological and Restorative Devices
510(k) Number
Prescription Use
(per 21 CFR 801.109)
OR
Mark N. Millenn
Restorative
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional format 1-2-96) _____________________________________________________________________________________________________________________________________________________
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