(59 days)
Pre-Amendment Capitello-Condylar Elbow System
Not Found
No
The summary describes a mechanical prosthetic device and its materials, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is used for arthroplasty of the elbow in patients suffering from conditions like rheumatoid arthritis, aiming to alleviate pain and improve motion, which are typical goals of therapeutic interventions.
No
The device is an elbow prosthesis, which is an implant for joint replacement, not a tool for diagnosing medical conditions. It is used to treat existing conditions rather than identify them.
No
The device description clearly states it is an elbow replacement composed of physical materials (cobalt-chromium-molybdenum alloy and ultra-high molecular weight polyethylene) and is intended for surgical implantation with bone cement. This is a hardware medical device.
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, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The provided description clearly states that the Capitello-Condylar Total Elbow Prosthesis is an elbow replacement. It is a physical implant designed to be surgically placed inside the body to replace a damaged elbow joint.
- Intended Use: The intended use is for arthroplasty (joint replacement) of the elbow in patients with specific conditions. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Capitello-Condylar Total Elbow Prosthesis is indicated for arthroplasty of the elbow in patients suffering from rheumatoid arthritis with intractable elbow pain, limited motion, and radiographically identifiable destruction, with relative preservation of bony stock. It is also indicated for use in certain older posttraumatic or osteoarthritic patients where a relatively low activity level is anticipated. This device is intended for cemented use.
Product codes (comma separated list FDA assigned to the subject device)
JDB
Device Description
The Captiello-Condylar Total Elbow Prosthesis is an elbow replacement which relies on existing soft tissue structures such as the medial collateral ligament and triceps tendon for support and stability. The Humeral component is composed of cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and has an intramedullary stem for fixation. The Ulnar component is composed of Co-Cr-Mo, with an articulating surface of ultra-high molecular weight polyethylene (UHMWPE). The device is designed to rely on soft tissue structures to support and absorb the forces which would otherwise be transmitted to the prosthesis, cement, or bone. The device is intended for use with bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow
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)
Extensive evaluation testing of the calcium stearate free UHMWPE indicates that the material meets or exceeds all current specifications for the material. In addition, results of both mechanical property and device function testing show that the material performs as well as or better than the UHMWPE currently being used.
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.
Pre-Amendment Capitello-Condylar Elbow System
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.
Not Found
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
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow 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 consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
6 1998 NOV
K98314/
510K Summarv Capitello-Condylar Total Elbow Prosthesis November 2, 1998
1. Submitter
Johnson & Johnson Professional, Inc. 325 Paramount Drive Ravnham, MA 02767 Deana Boushell, Regulatory Affairs Specialist, (508) 828-3107
Device Name 2.
| Proprietary Name: | Capitello-Condylar Total Elbow Prosthesis |
|---|---|
| Common Name: | Elbow Prosthesis |
| Classification Name: | Elbow joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class: | Class II, per CFR § 888.3160 |
3. Intended Use
The Capitello-Condylar Total Elbow Prosthesis is indicated for arthroplasty of the elbow in patients suffering from rheumatoid arthritis with intractable elbow pain, limited motion, and radiographically identifiable destruction, with relative preservation of bony stock. It is also indicated for use in certain older posttraumatic or osteoarthritic patients where a relatively low activity level is anticipated. This device is intended for cemented use.
4. Device Description
The Captiello-Condylar Total Elbow Prosthesis is an elbow replacement which relies on existing soft tissue structures such as the medial collateral ligament and triceps tendon for support and stability. The Humeral component is composed of cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and has an intramedullary stem for fixation. The Ulnar component is composed of Co-Cr-Mo, with an articulating surface of ultra-high molecular weight polyethylene (UHMWPE). The device is designed to rely on soft tissue structures to support and absorb the forces which would otherwise be transmitted to the prosthesis, cement, or bone. The device is intended for use with bone cement.
1
5. Predicate Device Comparison
The Capitello-Condylar Total Elbow Prosthesis is substantially equivalent in terms of intended use, materials, design, manufacturing, and function to the Pre-Amendment Capitello-Condylar Elbow System. Modifications to the UHMWPE used in the manufacture of some of the system components do not represent a significant change to the safety and effectiveness of the device.
Device Testing Summary 6.
Extensive evaluation testing of the calcium stearate free UHMWPE indicates that the material meets or exceeds all current specifications for the material. In addition, results of both mechanical property and device function testing show that the material performs as well as or better than the UHMWPE currently being used.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 6 1998
Deana M. Boushell, RAC Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive 02767-0350 Raynham, Massachusetts
Re: K983141 Capitello-Condylar Total Elbow Prosthesis Regulatory Class: II Product Code: JDB September 4, 1998 Dated: Received: September 8, 1998
Dear Ms. Boushell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Deana M. Boushell, RAC
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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K783/41
Capitello-Codylar Total Elbow Prosthesis INDICATIONS FOR USE
The Capitello-Condylar Total Elbow Prosthesis is indicated for arthroplasty of the elbow in patients suffering from rheumatoid arthritis with intractable elbow pain, limited motion, and radiographically identifiable destruction, with relative preservation of bony stock. It is also indicated for use in certain older posttraumatic or osteoarthritic patients where a relatively low activity level is anticipated. This device is intended for cemented use.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off)
Division of General Restorative Devices L983141
法
S Prescription Use (Per 21 CFR §801.109)
OR
510(k) Number
Over-the-Counter Use _No
(Optional Format 1-2-96)