(114 days)
Orthovita's Vitoss, Wright Medical's WMT-TCP Bone Graft Substitute
Not Found
No
The description focuses on the material properties and mechanical function of a bone void filler, with no mention of AI/ML terms or functionalities.
Yes
The device is described as a "Bone Void Filler" indicated for "filling the gaps or voids of osseous defects surgically created or resulting from trauma" and for "treatment of osseous defects." This description indicates its use in treating a condition or injury.
No
Explanation: The device is a bone void filler intended for structural support and to promote bone healing, not for diagnosing medical conditions.
No
The device description clearly states it is constructed of synthetic ß-tricalcium phosphate, which is a physical material, 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 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.
- TheriFil™ Bone Void Filler's Function: The provided text clearly states that TheriFil™ Bone Void Filler is a material used to fill gaps or voids in bone within the body. It is surgically implanted and resorbs over time, being replaced by bone. This is an in vivo (within the living organism) application, not an in vitro (in glass/outside the body) diagnostic test.
The description focuses on its physical properties, intended use in surgical procedures, and how it interacts with bone healing inside the patient. There is no mention of analyzing samples or providing diagnostic information based on laboratory tests.
N/A
Intended Use / Indications for Use
TheriFil™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriFil™ parts create an interlocking network within the defect site that resorbs during healing and is replaced by bone.
Product codes
MQV
Device Description
The TheriFil™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate, a commonly found mineral in bone. The porosity and geometric features of B-tricalcium phosphate create an interlocking network within the defect site that resorbs during healing and is replaced by native bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical performance testing conducted on TheriFil™ and Vitoss™ in a canine animal model according to indication yielded similar results based on tissue reaction, bone ingrowth, residual material, and mechanical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Orthovita's Vitoss™, Wright Medical's WMT-TCP Bone Graft Substitute
Reference Device(s)
Not Found
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 2 4 2003
K 03/090
Attachment - 6
510(k) Summary
1
THERICS, INC. 115 CAMPUS DRIVE RINCETON, NJ 0854 ELEPHONE: 609-514-7200 609-514-7219 FAX: E-MAIL: therics@therics.com
Image /page/1/Picture/1 description: The image contains the word "THERICS" in a stylized font. To the left of the word is a pattern of black dots arranged in a grid-like fashion. Above the word, there is some handwritten text that appears to be "K03/040". There is also the number "03" on the left side of the image.
JUL 2 4 2003
510(k) SUMMARY
Therics' TheriFil™ Bone Void Filler
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Submitter's Name:
Umberto V. Parrotta
609.514.7237 or 609.514.7200 (main) Telephone: Facsimile: 609.514.7219 Contact Person: Umberto V. Parrotta
Date Prepared:March 31, 2003
Name of Device and Name/Address of Sponsor
TRADE/PROPRIETARY NAME OF DEVICE:
TheriFil™ Bone Void Filler
ADDRESS:
115 Campus Drive Princeton, New Jersey 08540
Common or Usual Name:
Bone Void Filler. Synthetic Bone Void Filler. Synthetic Cancellous Bone Void Filler. Bone Graft Substitute. Synthetic Bone Substitute. Synthetic Cancellous Bone Substitute
Classification Name
Bone Void Filler
Predicate Devices
Orthovita's Vitoss™ Wright Medical's WMT-TCP Bone Graft Substitute
2
THERICS, INC. 15 CAMPUS DRIVE RINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-7219 FAX' E-MAIL: therics@therics.com
Image /page/2/Picture/1 description: The image shows the word "THERICS" next to a square made up of circles. The circles are arranged in a grid pattern, with the circles on the left side of the square being lighter and the circles on the right side of the square being darker. The word "THERICS" is written in a sans-serif font and is slightly offset to the right of the square. The image is black and white.
Intended Use / Indications for Use
TheriFil™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriFil™ parts create an interlocking network within the defect site that resorbs during healing and is replaced by bone.
Technological Characteristics and Substantial Equivalence
The TheriFil™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate, a commonly found mineral in bone. The porosity and geometric features of B-tricalcium phosphate create an interlocking network within the defect site that resorbs during healing and is replaced by native bone.
A summary of the physical and chemical characteristics of both TheriFilTM and Vitoss™ is below in Table 1.
| Characteristic | TheriFilTM | VitossTM | |
|---|---|---|---|
| Porosity | ~60% | ~80% | |
| Pore Area (µm2) | Mean | $3000 \pm 1200$ | $2700 \pm 2200$ |
| Min* | 40 | 40 | |
| Max | $3.5x10^5 + 2.1x10^5$ | $5.7x10^5 + 3.3x10^5$ | |
| Pore diameter (µm) | Mean | $60 \pm 12$ | $56 \pm 19$ |
| Min* | 7 | 7 | |
| Max | $640 \pm 220$ | $810 \pm 270$ | |
| True Density (grams/mL) | $1.530 \pm 0.001$ | $1.527 \pm 0.002$ | |
| Bulk Packing Density (grams/mL) | $0.53 \pm 0.02$ | $0.22 \pm 0.02$ | |
| Packing Porosity (%) | $65.7 \pm 1.4$ | $85.8 \pm 1.0$ |
Table 1. Physical characteristics of the TheriFil™ and Vitoss™ bone void fillers.
Percent porosity and pore area (um") were estimated using SEM images (n = 30) and are described in Attachment 134, Porosity Characterization. Data are shown as ave + stdev. The pore diameter was estimated from the pore area by assuming circular shaped pores. *All finite (✓ | OR | Over-The-Counter Use |
(Optional Format 1-2-96)