PROMOS SHOULDER

K032126 · Plus Orthopedics · HSD · Jan 8, 2004 · Orthopedic

Device Facts

Record IDK032126
Device NamePROMOS SHOULDER
ApplicantPlus Orthopedics
Product CodeHSD · Orthopedic
Decision DateJan 8, 2004
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3690
Device ClassClass 2
AttributesTherapeutic

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.

Device Story

PROMOS Shoulder is a modular shoulder prosthesis system designed to restore joint motion and eliminate pain. The system comprises a glenoid component and a modular humeral component. The glenoid component, made of UHMWPe, features a spherical articulating surface and four pegs for bone attachment. The humeral component includes a distal stem (cemented or cementless), body, inclination set, and humeral head. Components are assembled using Morse-type tapers and a ball screw mechanism, allowing for adjustable inclination and height of the humeral head. The device is intended for surgical implantation by orthopedic surgeons in a clinical/hospital setting. By replacing damaged joint surfaces with metallic and polymer components, the device aims to restore joint function and alleviate pain associated with arthritis, fractures, or necrosis.

Clinical Evidence

Bench testing only. Laboratory testing results indicate the device will survive expected in-vivo loading.

Technological Characteristics

Materials: UHMWPe (glenoid), Titanium alloy Ti6Al4V (stems/body/inclination set, ISO 5832-3), CoCrMo alloy (humeral heads, ISO 5832-12). Design: Modular humeral component with Morse-type taper and ball screw adjustment mechanism. Fixation: Cemented or cementless humeral stem; cemented glenoid. Sterilization: Not specified.

Indications for Use

Indicated for patients with advanced shoulder joint wear (degenerative, post-traumatic, or rheumatoid arthritis), humeral head fracture or avascular necrosis, and post-traumatic loss of joint configuration with functional impairment.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ JAN - 8 2004 : : ## 510(k) Summary K032126 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) _____________________________________________________________________________________________________________________________________________________ Page iii
Innolitics
510(k) Summary
Decision Summary
Classification Order
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