(385 days)
No
The 510(k) summary describes a mechanical implant (shoulder prosthesis) and its materials. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is an implantable prosthesis (RSP Modular Glenoid Baseplate) used to replace a joint, which falls under the definition of a therapeutic device.
No
The device description and intended use indicate it is an implantable medical device (a glenoid baseplate for shoulder replacement), not a diagnostic tool. Its purpose is to physically replace or augment a joint, not to gather information about a patient's condition.
No
The device description clearly details a physical implant made of titanium and other materials, intended for surgical implantation in the shoulder joint. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for replacing a damaged shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and construction of a physical implant designed to be surgically placed within the body. IVD devices are typically used to examine specimens taken from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
This device falls under the category of a surgical implant or prosthetic device, which are distinct from IVD devices.
N/A
Intended Use / Indications for Use
Indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. 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 purpose of this application is to include a new modularity option for the existing RSP baseplate. The RSP Modular Glenoid Baseblate is a multiple piece construct as opposed to a single piece construct as the predicate Reverse Shoulder Prosthesis Baseplate (K041066).
The RSP Modular Glenoid Baseplate is fabricated from wrought/forged Ti-6A 1-4V that conforms to ASTM F136. The bottom surface of the baseplate is porous coated with commercially pure titanium (ASTM F67 grade 2) beads. This is the same coating previously cleared under K974294. The baseplate is Hydroxyapatite coated that conforms to ASTM F1185. The distal surface of the glenoid baseplate is porous coated with an incorporated 6.5mm cancellous screw and is intended to be used with four peripheral screws (3.5mm non-locking and/or 5mm locking and non-locking) for additional fixation.
The RSP Modular Glenoid Baseplate female taper of the adapter have geometry identical to those used in the predicate Turon Shoulder (K080402).
There are no changes to sterilization, packaging, indications or intended use.
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)
Non-Clinical Testing: Mechanical fatigue testing, Dynamic testing. Results of non-clinical testing demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
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.
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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized human figure with three lines representing the head, body, and legs. The figure is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the top half of the circle, with the figure centered below.
Public Health Service
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. Mr. William Garzon Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas, 78758
Re: K130550
Trade/Device Name: RSP Modular Glenoid Baseplate 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: February 13, 2014 Received: February 18, 2014
Dear Mr. Garzon:
This letter corrects our substantially equivalent letter of March 24, 2014.
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. Iisting 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
K130550 510(k) Number (if known):
Device Name: RSP Modular Glenoid Baseplate
Indications for Use:
Indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessury to use the device. The glenoid baseplate is intended for comentless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
Prescription Usc 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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 1 of 1
2
Page 2 - Mr. William Garzon
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/Resourcesfor You/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
3
MAR 2 4 2014
510(k) Summary
Date: March 1, 2013
Manufacturer: Encore Medical, L.P. Trade Name: DJO Surgical 9800 Metric Blvd Austin, TX 78758
Contact Person: William Garzon Regulatory Affairs Specialist Phone: (512) 834-6391 Fax: (512) 834-6313 Email: william.garzon@djoglobal.com
| Product | Classification | Product Code |
|---|---|---|
| RSP Modular Glenoid Baseplate | Class II | KWS |
| Product Code | Regulation and Classification Name |
|---|---|
| KWS | Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3660 |
Description:
The purpose of this application is to include a new modularity option for the existing RSP baseplate. The RSP Modular Glenoid Baseblate is a multiple piece construct as opposed to a single piece construct as the predicate Reverse Shoulder Prosthesis Baseplate (K041066).
The RSP Modular Glenoid Baseplate is fabricated from wrought/forged Ti-6A 1-4V that conforms to ASTM F136. The bottom surface of the baseplate is porous coated with commercially pure titanium (ASTM F67 grade 2) beads. This is the same coating previously cleared under K974294. The baseplate is Hydroxyapatite coated that conforms to ASTM F1185. The distal surface of the glenoid baseplate is porous coated with an incorporated 6.5mm cancellous screw and is intended to be used with four peripheral screws (3.5mm non-locking and/or 5mm locking and non-locking) for additional fixation.
The RSP Modular Glenoid Baseplate female taper of the adapter have geometry identical to those used in the predicate Turon Shoulder (K080402).
There are no changes to sterilization, packaging, indications or intended use.
Indications for Use:
Indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. 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:
Comparable Features to Predicate Device(s):
4
Features comparable to predicate devices include the same indications, sterilization, packaging and intended use.
Non-Clinical Testing:
Mechanical fatigue testing, Dynamic testing. Results of non-clinical testing demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
Clinical Testing: None provided