(85 days)
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Not Found
No
The summary describes a ceramic bone void filler and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a bone void filler or bone graft substitute designed to aid in the healing process of bony defects, which directly relates to treating a medical condition or improving health.
No
The device is a bone void filler or bone graft substitute, used for treatment by filling gaps, not for diagnostic purposes.
No
The device description clearly indicates that HATriC™ is a physical bone void filler made of ceramic calcium phosphate in a block configuration. It is a tangible implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a bone void filler or bone graft substitute used in vivo (within the body) to fill bony voids and gaps. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a ceramic calcium phosphate block designed to be implanted into bone. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such tests.
Therefore, HATriC™ is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use for HATriC™ is that of a bone void filler or bone graft substitute in bony voids or gaps which are not intrinsic to the stability of the bony structure (i.e. extremities, pelvis, or spine). These bony voids and gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. HATriC™ may be used as a bone graft substitute for autograft or allograft when these grafts are undesirable or unavailable.
When used for posterolateral fusions, the HATriC™ must be used with autograft bone material and the ratio of autograft bone material to HATriC™ must be in the range of 1.25cm³ of autograft bone to 1cm3 of HATriC™.
HATriC™ is a bone void filler or bone graft substitute that resorbs and is replaced with bone during the healing process. HATriC™ is not intended to be a load-bearing device. Therefore rigid fixation techniques may often be recommended.
In addition, when used with Arthrex Opening Osteotomy Systems' or substantially equivalent systems' plates and screws, HATriC™ is intended to be used as a bone void filler or bone graft substitute in femoral or tibial osteotomies. HATriC™ is to be used in association with adequate post-operative immobilization.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
HATriC™ is a bone void filler or bone graft substitute. HATriC™ is designed as a block of two-phase ceramic calcium phosphate consisting of 60% hydroxyapatite and 40% B-tricalcium phosphate in a wedge configuration. HATriC™presents as a multidirectional interconnected porosity structure, similar to that of hyman cancellous bone. The HATriC™ implant resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
extremities, pelvis, or spine, femoral or tibial osteotomies
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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 OF SAFETY AND EFFECTIVENESS Arthrex HATriC ™
| NAME OF SPONSOR: | Arthrex, Inc.
1370 Creekside Boulevard
Naples, Florida 34108-1945 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust, RAC
Sr. Regulatory Affairs Specialist
Telephone: (239) 643-5553 extension 1251
FAX: (239) 598-5539 |
| TRADE NAME: | HATriC™ |
| COMMON NAME: | Bone Void Filler |
| CLASSIFICATION: | Resorbable Calcium Salt Bone Void Filler Device
21 CFR 888.3045 |
| DEVICE PRODUCT CODE: | MQV |
DEVICE DESCRIPTion AND INTENDED USE:
HATriC™ is a bone void filler or bone graft substitute. HATriC™ is designed as a block of two-phase ceramic calcium phosphate consisting of 60% hydroxyapatite and 40% B-tricalcium phosphate in a wedge configuration. HATriC™presents as a multidirectional interconnected porosity structure, similar to that of hyman cancellous bone. The HATriC™ implant resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues.
The intended use for HATriC™ is that of a bone void filler or bone graft substitute in bony voids or gaps which are not intrinsic to the stability of the bony structure (i.e. extremities, pelvis, or spine). These bony voids and gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. HATriC™ may be used as a bone graft substitute for autograft or allograff when these grafts are undesirable or unavailable.
When used for posterolateral fusions, the HATriC™ must be used with autograft bone material and the ratio of autograft bone material to HATriC™ must be in the range of 1.25cm³ of autograft bone to 1cm3 of HATriC™.
HATriC™ is a bone void filler or bone graft substitute that resorbs and is replaced with bone during the healing process. HATriC™ is not intended to be a load-bearing device. Therefore rigid fixation techniques may often be recommended.
In addition, when used with Arthrex Opening Ostectorny Systems' or substantially equivalent systems' plates and screws, HATriC™ is intended to be used as a bone void filler or bone graft substitute in femoral or tibial osteotomies. HATriC™ is to be used in association with adequate post-operative immobilization.
SUBSTANTIALLY EQUIVALENCE
HATriC™ is substantially equivalent to the predicate devices where basic features and intended uses are the same. Any design differences between the HATriC™ device are considered minor and do not raise questions concerning safety and effectiveness. Based on clinical data and mechanical rationale submitted, when used with Arthrex Opening Osteotomy Systems' or substantially equivalent systems' plates and screws, HATriC™ is intended to be used as a bone void filler or bone graft substitute in femoral or tibial osteotomies, which falls within the general indications of the predicate/marketed devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare and medicine.
Public Health Service
MAY 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sally Foust, RAC Senior Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K040381 Trade/Device Name: HATriC™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: February 16, 2004 Received: February 18, 2004
Dear Ms. Foust:
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 usc 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 he 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); labcling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Sally Foust, RAC
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,
Mark N. Milburn
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
3
51( (k) Number (if known): K040381
Device Name: HATriC™
The intended use for HATriC™ is that of a bone void filler or bone graft substitute in The intended use for HAT nC = 1s intribute to the stability of the bony structure (i.e.
bor y voicls or gaps which are not intrinsit to the stablily create bor y voicls or gaps which are not intinution to the surgically created
extremities, pelvis, or spine). These bony voids and gaps may be surgically created extremities, pelvis, or spine). These bony volus and gapoth injury to the bone. HATric™
osseous defects or osseous defects created from traumatic injury the bone the osseous detects or osseous delects created from audinated with these grafts are
may be used as a bone graft substitute for autograft when these grafts are unclesirable or unavailable.
Wh en used for posterolateral fusions, the HATriC™ must be used with autograft bone
t the read for a free for the restable to material to HATriC™ must he in the range of When used for posterolateral institutes material to HATriO™ must be in the range of
material and the ratio of autografit bone material to HATriC™ 1.25cm³ to 2.4cm³ of autograft bone to 1cm³ of HATriC™.
HATriC™ is a bone void filler or bone graft substitute that resorbs and is replaced with HATriC™ is a bone vold filler or bone gran substitute that roomborded to be a load-bearing device.
bo ne during the healing process. HATriC™ is not intended to be a load-bea bo le dunny the nealing prosocer "... www.
Therefore rigid fixation techniques may often be recommended.
In addition, when used with Arthrex Opening Osteotomy Systems' or substantially In addition, when used with Afthrex Opening Ostooding Ostoological of the Proided on a bone void filler or bone graft substitute in femoral or tibial osteotomies.
H/‹TriC™ is to be used in association with adequate post-operative immobilization.
Prescription Use (P 3rt 21 (FR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(F LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDR
Mark X Millhusan
Division Staff
Division of General, Restorative, and Neurological Devices
510(k) Number K040381
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