(79 days)
Not Found
No
The 510(k) summary describes a synthetic, injectable, resorbable bone void filler and its performance compared to predicate devices. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the material properties and biological function of the filler.
No.
The device is a bone void filler intended to fill bony voids or gaps, which resorbs and is replaced by bone during healing, rather than actively providing a therapeutic effect.
No
The device is a bone void filler intended to fill bony voids or gaps and is replaced by bone during healing. It is a treatment device, not a diagnostic one.
No
The device description clearly states that Osteofix™ Bone Void Filler is a "synthetic, injectable, resorbable, Bone Void Filler," indicating it is a physical material intended for implantation, not a software product.
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 Osteofix™ Bone Void Filler is used to fill bony voids or gaps in the skeletal system. This is a therapeutic or structural application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms it's a synthetic, injectable, resorbable bone void filler, which aligns with a device used for physical repair or support within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for a health issue. The device is directly applied to the bone.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. Osteofix™ is used in vivo (inside the body) for a structural purpose.
N/A
Intended Use / Indications for Use
Osteofix™ Bone Void Filler is indicated for use to fill bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteofix™ Bone Void Filler is intended to be injected 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 provides a Bone Void Filler that resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Osteofix™ Bone Void Filler is a synthetic, injectable, resorbable, Bone Void Filler.
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)
The performance of Osteofix™ has been compared to Pro Osteon 500R in a comparison study. Results demonstrated substantially similar rates of resorption. Results of bench testing demonstrate that Osteofix™ Bone Void Filler meets its specifications and does not raise new issues of safety or effectiveness. In all instances, Osteofix™ Bone Void Filler functioned as intended.
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.
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
§ 888.3045 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
510(k) SUMMARY
CALCITEC, INC. OSTEOFIX™ BONE VOID FILLER
APR 1 2 2007
Sponsor's Name, Address, Telephone Number, Contact Person and Date Prepared
Calcitec, Inc 7000 Bee Cave Road Suite 250 Austin, TX 78746 Phone: 512-306-9555 Facsimile: 512-306-9557
Contact Person: Brooke Campbell
Date Prepared: January 23, 2007
Name of Device
Osteofix™ Bone Void Filler
Common or Usual Name
Bone Void Filler, Bone Void Filler
Classification Name
Class II Classification: Classification Name: Filler, bone void, calcium compound
Predicate Devices
- Interpore Cross International, Pro Osteon 500R (K990131) .
- Berkelev Advanced Biomaterials, Inc., Cem-Ostetic (K040405) ●
- Synthes, Norian SRS Bone Void Filler (K011897) ●
Intended Use / Indications for Use
Osteofix™ Bone Void Filler is indicated for use to fill bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteofix™ Bone Void Filler is intended to be injected 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 provides a Bone Void Filler that resorbs and is replaced with bone during the
પ્રધ્યમ
1
aling process.
chaological Characteristics
eofix™ Bone Void Filler is a synthetic, injectable, resorbable, Bone Void Fil ﺍﻟﻤﻌﻠﺎﺓ Calcina ) ﺃﻥ ﻣﺴﻠﺴﻞ ﺍﻟﻤﺸﺎﻫﺪﺓ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺪ
Performance Data
e performance of Osteofix™ has been compared to Pro Osteon 500R in a si nparison study. Results demonstrated substantially similar rates of resorpt aterial.
sults of bench testing demonstrate that Osteofix™ Bone Void Filler meets its specifications
I does not raise new issues of safety or effectiveness. In all instances, Osteofi ler functioned as intended.
compatibility Data
led for permanent blood contacting devices, and the materials w ocompatible. Additionally, the same materials are commonly used in similar medic