(35 days)
No
The description focuses on the material properties and biological function of a bone void filler, with no mention of AI or ML technologies.
Yes
The device is described as a bone void filler intended for the repair and regeneration of bone in skeletal defects, which directly addresses a medical condition or ailment, indicating a therapeutic purpose.
No
The device is a bone void filler intended for the repair of bony defects, not for diagnosing medical conditions.
No
The device description clearly states it is a "porous calcium phosphate bone void filler" and an "implant," indicating it is a physical material intended for implantation, not software.
Based on the provided information, the CELLPLEX™ TCP Synthetic Cancellous Bone is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- CELLPLEX™ Function: The description clearly states that CELLPLEX™ is a bone void filler implanted directly into the body to repair bony defects. It is a surgical implant that facilitates bone regeneration.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens outside of the body.
Therefore, CELLPLEX™ TCP Synthetic Cancellous Bone falls under the category of a medical device, specifically a bone graft substitute, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CELLPLEX™ TCP Synthetic Cancellous Bone can be combined with autogenous bone marrow aspirate and/ or blood and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The CELLPLEX™ TCP Synthetic Cancellous Bone is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.
Product codes
MQV/87, MQV
Device Description
CELLPLEX™ TCP Synthetic Cancellous Bone is a porous calcium phosphate bone void filler made from tricalcium phosphate for the repair of bony defects. It is osteoconductive with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile for single patient use. CELLPLEX™ TCP Synthetic Cancellous Bone guides the three-dimensional regeneration of bone in the defect site into which it is implanted. Pores in the device range from 100 to 400 um nominally. When CELLPLEX™ TCP Synthetic Cancellous Bone is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant, filling the pores with new bone. As the implant is bioabsorbed, bone grows into the space previously occupied by the bone graft substitute.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
the skeletal system (i.e., the extremities, spine and pelvis)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
JUL 17 2003
Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in large, bold, black letters. Above the word, there is a handwritten code or number, "K031817". Below the word, there are three black lines that appear to be part of a logo or design element.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of CELLPLEX™ TCP Synthetic Cancellous Bone.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | June 11, 2003 |
| Contact Person: | Ehab M. Esmail |
| Senior Manager of Regulatory Affairs | |
| Phone: 901-867-4732 Fax: 901-867 4630 | |
| Proprietary Name: | CELLPLEX™ TCP Synthetic Cancellous Bone |
| Common Name: | Bone Graft Substitute |
| Classification Name and Reference: | Filler, Calcium Sulfate Preformed Pellets, |
| Unclassified | |
| Device Product Code and Panel Code: | MQV/87 |
DEVICE INFORMATION
A. INTENDED USE/ INDICATIONS
CELLPLEX™ TCP Synthetic Cancellous Bone can be combined with autogenous bone marrow aspirate and/ or blood and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The CELLPLEX™ TCP Synthetic Cancellous Bone is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.
B. DEVICE DESCRIPTION
CELLPLEX™ TCP Synthetic Cancellous Bone is a porous calcium phosphate bone void filler made from tricalcium phosphate for the repair of bony defects. It is osteoconductive with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile for single patient use. CELLPLEX™ TCP Synthetic Cancellous Bone guides the three-dimensional regeneration of bone in the defect
headquarters
Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone
international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy
905.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK
011.49.4161.745130 Germany
1
site into which it is implanted. Pores in the device range from 100 to 400 um nominally. When CELLPLEX™ TCP Synthetic Cancellous Bone is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant, filling the pores with new bone. As the implant is bioabsorbed, bone grows into the space previously occupied by the bone graft substitute.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material composition, and design features of the CELLPLEX™ TCP Synthetic Cancellous Bone are substantially equivalent to the intended use, material composition, and design features of the previously cleared WMT-TCP Bone Graft Substitute (K022629). The mechanical properties of the CELLPLEX™ TCP Synthetic Cancellous Bone are substantially equivalent to the VITOSS™ Scaffold Synthetic Cancellous Bone Void Filler (K994337). The safety and effectiveness of the CELLPLEX™ TCP Synthetic Cancellous Bone is adequately supported by the substantial equivalence information, and testing results provided within this Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. The symbol on the right features three curved lines that resemble a stylized human figure.
Public Health Service
JUL 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ehab M. Esmail Senior Manager of Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002
Re: K031817
Trade Name: CELLPLEX TCP Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: June 11, 2003 Received: June 12, 2003
Dear Mr. Esmail:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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
3
Page 2 – Mr. Ehab M. Esmail
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
O Marsh A. Mclennan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word, there are two stylized, horizontal lines that appear to be converging towards the right. The letters "TM" are located at the bottom right corner of the image.
CELLPLEX™ TCP Synthetic Bone Substitute INDICATIONS STATEMENT
CELLPLEX™ TCP Synthetic Cancellous Bone can be combined with autogenous bone marrow aspirate and/ or blood and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The CELLPLEX™ TCP Synthetic Cancellous Bone is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Division of General Restorative Devices
(Division Sign-Off)
510(k) Number
Mark A. Milliman
ision Sign-O In ision of General. Restorative cad Neurologica
510(k) Number.
headquarters Wright Medical Technology, Inc.
5677 Airline Road Arlington, TN 38002
901.867.9971 phone
international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy
905.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK
011.49.4161.745130 Germany