(91 days)
No
The document describes a mechanical implant (reverse shoulder prosthesis) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implantable prosthesis designed to replace and restore the function of a damaged shoulder joint, which qualifies it as a therapeutic device.
No
Explanation: The provided text describes a medical implant (Reverse Shoulder Prosthesis) designed for treatment, not for diagnosing medical conditions. Its purpose is to replace parts of the shoulder joint in certain patients.
No
The device description clearly outlines physical components such as a glenoid head, humeral socket, humeral stem, glenoid baseplate, and baseplate screws, which are all hardware.
No, 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 provided text describes a Reverse Shoulder Prosthesis, which is an implantable medical device designed to replace a damaged shoulder joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use clearly states that the device is for patients with specific shoulder conditions and is surgically implanted. It does not involve testing samples from the body.
Therefore, based on the description and intended use, the Reverse Shoulder Prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Reverse Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:
- . In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.
- In cases of bone defect in proximal humerus. .
The patient's joint must be anatomically and structurally suited to receive the selected implant(s).
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS
Device Description
The Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff. failed hemi or total shoulder arthroplasty with irreparable rotator cuff, and for fracture in which the tuberosity and rotator cuff are irreparable. The RSP is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup attached to the humeral stem. The components included in this system are a glenoid head, a humeral socket, a humeral stem, a glenoid baseplate, and baseplate screws.
The Monoblock design consists of:
- . a non-modular stem designed by joining the humeral socket with the humeral stem (sizes 6, 7, 8, 10 and 12);
- . humeral inserts in size 44 semi-constrained UHMWPe and +4 offset inserts in sizes 32, 36, 40 and 44 (standard and semi-constrained UHMWPe). Currently cleared sizes of inserts (32, 36, 40, and 44 in standard poly and size 32, 36, and 40 semi-constrained UHMWPe) are also compatible with the monoblock design.
- . glenoid components will be the same as currently cleared under K 100741, K092873, K051075, and K041066
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, glenohumeral 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: After completing review of prior non-clinical testing conducted for this system and submitted under K100741, K092873, K051075, and K041066, it was concluded that additional testing was not necessary to support equivalence.
Clinical Testing: None provided.
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.
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.
K100741, K092873, K051075, K041066
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin. Texas 78758-5445
Re: K103208
Trade/Device Name: Reverse® Shoulder Prosthesis Monoblock Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: October 29, 2010 Received: November 1, 2010
Dear Ms. Hutto
This letter corrects our substantially equivalent letter of January 31, 2011.
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
1
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 Industry and Consumer Education at its toll-free 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 i (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: Reverse Shoulder Prosthesis Monoblock
Indications for Use:
Reverse® Shoulder Prosthesis Monoblock Indications for Use
The Reverse Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:
- . In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.
- In cases of bone defect in proximal humerus. .
The patient's joint must be anatomically and structurally suited to receive the selected implant(s).
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
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 ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103208
Page 1 of 1
3
K103208
p.1/2
JAN 3 1 201
Summary of Safety and Effectiveness
Date: January 26, 2011
Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (760) 597-8466 Email: teffany.hutto@djosurgical.com
| Product | 510(k) Number, Classification | Product Code | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| Reverse® Shoulder Prosthesis Monoblock | K103208, Class II | KWS | KWS | Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3660 |
Description:
The Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff. failed hemi or total shoulder arthroplasty with irreparable rotator cuff, and for fracture in which the tuberosity and rotator cuff are irreparable. The RSP is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup attached to the humeral stem. The components included in this system are a glenoid head, a humeral socket, a humeral stem, a glenoid baseplate, and baseplate screws.
The Monoblock design consists of:
- . a non-modular stem designed by joining the humeral socket with the humeral stem (sizes 6, 7, 8, 10 and 12);
- . humeral inserts in size 44 semi-constrained UHMWPe and +4 offset inserts in sizes 32, 36, 40 and 44 (standard and semi-constrained UHMWPe). Currently cleared sizes of inserts (32, 36, 40, and 44 in standard poly and size 32, 36, and 40 semi-constrained UHMWPe) are also compatible with the monoblock design.
- . glenoid components will be the same as currently cleared under K 100741, K092873, K051075, and K041066
Indications for Use:
The Reverse Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:
- In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.
- In cases of bone defect in proximal humerus. .
The patient's joint must be anatonically and structurally suited to receive the selected implant(s).
The glenoid baseplate is intended for cementless application of screws for fixation. The humeral stem is intended for cemented use only.
Predicate Device:
· K082120 - Tornier Aequalis@-Reversed Fracture prosthesis
4
K103208
p. 2/2
Comparable Features to Predicate Device(s):
- Single cup diameter accepts multiple articular t diameters
- Multiple stem diaphysis diameters .
- Titanium alloy construction
- . Coated Metaphysis
- . Single piece stem/metaphysis construction
- . Anatomic positioning of tuberosities
- . Bone graft attachment
- . Medial cerclage suture hole
Non-Clinical Testing: After completing review of prior non-clinical testing conducted for this system and submitted under K100741, K092873, K051075, and K041066, it was concluded that additional testing was not necessary to support equivalence.
Clinical Testing: None provided.