(48 days)
No
The document describes a mechanical implant (shoulder prosthesis) and its components. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are focused on mechanical and material properties.
Yes
The device is a prosthesis designed to replace a deficient shoulder joint, which is a therapeutic intervention aimed at restoring function and alleviating symptoms.
No
The device description and intended use clearly state that it is a prosthetic implant for shoulder replacement, not a device for diagnostic purposes.
No
The device description clearly outlines physical components like a glenoid bead, humeral stem, baseplate, and screws, indicating it is a hardware-based medical device.
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 designed to replace a damaged shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a prosthetic shoulder joint (stems, baseplates, sockets, screws). This aligns with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, tissue, etc.) or providing information for diagnosis.
- Performance Studies: The performance studies listed are related to the mechanical and biological compatibility of the implant, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Reverse® Shoulder Prosthesis (RSP®) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy, 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.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
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. (For cemented implantation only)
- 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 or cementless use.
Product codes
PHX, KWS
Device Description
The RSP system is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulations fits into a metal cup that is joined to the humeral stem. The components included in this system are a glenoid bead, a humeral stem. The component baseplate, and baseplate screws. The standard RSP system consists of a modular components which include a humeral stem, humeral socket inset, glenoid baseplate, glenoid baseplate, which screws. The RSP Monoblock stem includes a humeral socket and humeral socket
The modification outlined in this application consists of an addition of a humeral socket insert infused with pure liquid pharmaceutical grade alpha-tocopherol into the material.
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: Axial Push Out, Lever Out, Torsion, Izod Impact, Small Punch, Tensile, FTIR Analysis, Animal Implant, Cycotoxicity, and Fatigue. All testing has determined that the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RSP Shoulder System, DJO Surgical, K041066, K051075, K092873
Reference Device(s)
RSP Monoblock Humeral Stem, DJO Surgical K100741, K03208 FMP Acetabular Liner, DJO Surgical, K130365 RSP Monoblock Accessories, DJO Surgical, K130048
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
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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion.
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. Christine Chesnutt Department Coordinator- 1 9800 Metric Boulevard Austin, Texas 78758
Re: K141006
Trade/Device Name: Reverse® Shoulder Prosthesis, 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: May 5, 2014 Received: May 6, 2014
Dear Ms. Chesnutt:
This letter corrects our substantially equivalent letter of June 5, 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
1
Page 2 - Ms. Christine Chesnutt
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 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 (ifknown): K141006
Device Name: Reverse Shoulder Prosthesis
Indications for Use:
Reverse® Shoulder Prosthesis Indications for Use
The Reverse® Shoulder Prosthesis (RSP®) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy, 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.
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.
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)
Page 1/2
3
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. (For cemented implantation only)
- 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 or cementless use.
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 ofCDRH, Office ofDevice Evaluation (ODE)
Page 2/2
4
JUN 0 5 2014
Page 1 of 2
K141006
510(k) Summary
Date: May 27, 2014
Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Christine Chesnutt Department Coordination-1 Phone: (512) 834-6207 Fax: (512) 834-6313 Email: Christine.Chesnutt@djosurgical.com
| Product | Classification | Product Code | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| Reverse® Shoulder Prosthesis | Class II | KWS | KWS | Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888 3660 |
| Reverse® Shoulder Monoblock | Class II | KWS |
Description:
The RSP system is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulations fis into a metal oup that is joined to the humeral stem. The components included in this system are a glenoid bead, a humeral stem. The component baseplate, and baseplate screws. The standard RSP system consists of a modular components which include a humeral stem, humeral socket inset, gleanoid baseplate, glenoid baseplate, which
screws. The RSP Monoblock stem includes a bument test gemoid baseplate, glenoid he screws. The RSP Monoblock socket hiser, greend baseplate, glenoid baseplate, and humeral socket and humeral socket
The modification outlined in this application consists of an addition of a humeral socket insert infused with pure liquid pharmaceutical grade alpha-tocopheral into the material.
Indications for Use:
The Reverse® Shoulder Prosthesis (RSP®) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy, 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.
The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a finctional deltoid muscle with a grossly deficient rolators shoulder joint with a finctional deltoid muse 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 the shoulders.
cemented implayion only) cemented implantation only) - 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 or cementless use.
5
K141006
Predicate Devices:
RSP Shoulder System, DJO Surgical, K041066, K051075, K092873 RSP Monoblock Humeral Stem, DJO Surgical K100741, K03208 FMP Acetabular Liner, DJO Surgical, K130365 RSP Monoblock Accessories, DJO Surgical, K130048
Comparable Features to Predicate Device(s): Features comparable to the RSP Shoulder System insert include the same dimensions ond sizing. Features comparable to the RSP Monoblock includer System insection indications and surgical implantation technique, and intended use. Features comparable to the FMP Acceabular Liner are materials, and sterlization. There are no features included in the FMP
that are not Liready cleared in a prodicate design list to lo that are not already cleared in a predicate device listed above.
Non-Clinical Testing: Axial Push Out, Lever Out, Torsion, Izod Impact, Small Punch, Tensile, FTIR Analysis, Animal Implant, Cycotoxicity, and Fatigue. All testing has determined that the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided.
.