(48 days)
Therics' TheriFil™ Bone Void Filler, Orthovita's Vitoss™
Not Found
No
The document describes a bone void filler material and its physical properties, with no mention of AI or ML technology being used in the device itself or its function. The mention of SEM image analysis for porosity characterization does not indicate the use of AI/ML for this analysis.
Yes
The device is described as "Bone Void Filler" and is "indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma," which aligns with the definition of a therapeutic device as it is intended to treat a condition.
No
The device is a bone void filler intended for use in filling osseous defects, functioning as a structural replacement that resorbs and is replaced by bone. It does not perform any diagnostic function.
No
The device description clearly states it is constructed of synthetic ß-tricalcium phosphate, which is a physical material, not software. The mention of image processing is for characterization of the physical material, not the primary function of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that TheriLink™ Bone Void Filler is used to fill gaps or voids in bone defects within the body (in vivo). It is a surgical implant intended to be placed directly into the skeletal system.
- Device Description: The description details the material and structure of the bone void filler itself, which is a physical implant.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information about a physiological state, health, or disease.
While the device description mentions using SEM images for characterization (which is a laboratory technique), this is a method used to analyze the physical properties of the device itself, not to diagnose or monitor a patient's condition using a biological sample.
Therefore, TheriLink™ Bone Void Filler falls under the category of a surgical implant or medical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TheriLink™ 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). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.
Product codes
MQV
Device Description
The TheriLink™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate (ß-TCP), a commonly found mineral in bone. The porosity and geometric features of ß-tricalcium phosphate create a 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Therics' TheriFil™ Bone Void Filler, Orthovita's Vitoss™
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
KO40134 THERICS' ャートは1人を見える11、そのために1本に1人に
THERICS, INC. I 15 Campus Drive PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-7219 FAX: E-MAIL: therics@therics.com
MAR - 9 2004
510(k) SUMMARY
Therics' TheriLink™ 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: January 19, 2004
Name of Device and Name/Address of Sponsor
TRADE/PROPRIETARY NAME OF DEVICE:
TheriLink™ 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
Therics' TheriFil™ Bone Void Filler Orthovita's Vitoss™
1
THERICS, INC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-7219 FAX: E-MAIL: therics@therics.com
Image /page/1/Figure/1 description: The image shows a logo for a company called "THERICS". The logo features a stylized letter "T" above the company name. Below the company name, the text "LASER ENGINEERING SPECIALISTS" is present, indicating the company's area of expertise.
Intended Use / Indications for Use
cu ose / Indications 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). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.
Technological Characteristics and Substantial Equivalence
The TheriLink™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate (ß-TCP), a commonly found mineral in bone. The porosity and geometric features of ß-tricalcium phosphate create a 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 TheriLink™ and TheriFil™ is below in Table 1.
| Characteristic | TheriLink™ | TheriFil™ |
|---|---|---|
| Porosity (%) | 58 ± 2.2 | 59 ± 5.3 |
| Pore Area (µm²) | Mean | |
| 2500 ± 900 | 3000 ± 1200 | |
| Min* | ||
| 40 | 40 | |
| Max | ||
| $4.9 x10^5 ± 1.9 x10^5$ | $3.5 x10^5 ± 2.1 x10^5$ | |
| Pore diameter (µm) | Mean | |
| 55 ± 11 | 60 ± 12 | |
| Min* | ||
| 7 | 7 | |
| Max | ||
| 770 ± 170 | 640 ± 220 | |
| True Density (grams/mL) | 1.5 | 1.5 |
| Crystallinity | β-TCP > 75% | β-TCP > 75% |
Table 1. Physical and chemical characteristics of the TheriLink™ and TheriFil™ .
Percent porosity and pore area (um') were estimated using SEM images (n = 18) and are described in Attachment - 13A, I crosity Characterization. Data are shown as ave ± sidev. The pore diameter was estimated from the pore area by assuming r circular shaped pores. * All finite (