(93 days)
Not Found
No
The summary describes a mechanical orthopedic implant and a modification to an existing cleared device. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a prosthesis indicated for patients with severe arthropathy or a previously failed joint replacement, which clearly states its function is to treat a medical condition.
No
Explanation: This device is a prosthesis (an implanted medical device) used for joint replacement, not a tool for diagnosing medical conditions. Its purpose is to treat severe arthropathy or a failed joint replacement by physically replacing parts of the shoulder joint.
No
The device description clearly states it is a "Reverse Shoulder Monoblock Prosthesis" and describes physical components like a humeral stem, socket, inserts, glenoid head, baseplate, spacer, and screw. This indicates a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The provided text describes a Reverse Shoulder Monoblock Prosthesis, which is an implantable device used to replace a damaged shoulder joint within the body.
- Intended Use: The intended use clearly states it's for patients with specific shoulder conditions requiring joint replacement. This is a surgical procedure performed in vivo.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Reverse Shoulder Monoblock Prosthesis 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
PHX, KWS
Device Description
This is a modification to the RSP Monoblock Stem cleared under K100741. The cleared RSP Monoblock Prosthesis system consists of a monoblock humeral stem with socket, humeral socket inserts, glenoid head, and glenoid head baseplate.
This change consists of the addition of an 8mm spacer and screw placed between the socket insert and the humeral shell portion of the RSP Monoblock stem to allow for 8mm humeral offset.
There is no change to the intended use or fundamental scientific technology. This includes no changes to packaging or sterilization.
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
Prescription Use
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
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing includes torque, lever out strength, load cycle, and screw torque.
Clinical Testing: None provided.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an abstract symbol that resembles a person embracing another person.
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 7858-5445
Re: K111061
Trade/Device Name: Reverse® Shoulder Monoblock Prosthesis 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: June 20, 2011 Received: June 21, 2011
Dear Ms. Hutto:
This letter corrects our substantially equivalent letter of July 20, 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
1
Page 2 -- Ms. Teffany Hutto
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 (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 Monoblock Prosthesis
Indications for Use:
Reverse® Shoulder Monoblock Prosthesis Indications for Use
The Reverse Shoulder Monoblock Prosthesis 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.
X Prescription Use (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. Mellarson
(Division Sign Oft)( Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111061
3
Summary of Safety and Effectiveness
Date: July 15, 2011
Manufacturer: DJO Surgical (legally Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djosurgical.com
| Product | 510(k) Number and Classification | Product Code | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| Reverse® Shoulder Monoblock Prosthesis | K111061, Class II | KWS | KWS | Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3660 |
Description: This is a modification to the RSP Monoblock Stem cleared under K100741. The cleared RSP Monoblock Prosthesis system consists of a monoblock humeral stem with socket, humeral socket inserts, glenoid head, and glenoid head baseplate.
This change consists of the addition of an 8mm spacer and screw placed between the socket insert and the humeral shell portion of the RSP Monoblock stem to allow for 8mm humeral offset.
There is no change to the intended use or fundamental scientific technology. This includes no changes to packaging or sterilization.
Indications for Use: The Reverse Shoulder Monoblock Prosthesis 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.
Predicate Device:
- DJO Surgical Reverse Shoulder Prosthesis K041066, K051075, K100741 ●
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications, sterilization, and intended use.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing includes torque, lever out strength, load cycle, and screw torque.
Clinical Testing: None provided.