(65 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant (compression screws) and associated instrumentation. There is no mention of software, algorithms, image processing, AI, or ML in the intended use, device description, or performance studies summary.
Yes
The device is indicated for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation, all of which are considered therapeutic interventions for medical conditions.
No
The device is a compression screw intended for bone reconstruction and fixation, not for diagnosing medical conditions.
No
The device description explicitly states it includes sterile titanium self-drilling and self-tapping screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use of the BITE™ Compression Screws clearly state that they are surgical implants used for bone reconstruction, fracture repair, and fixation within the body. They are physical devices inserted into bone.
The information provided describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
EDGE Orthopaedics' BITE™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. BITE Compression Screws are intended for single use only.
BITE Compression Screws are intended for use over a guide pin or wire. EDGE Orthopaedics' washers may be used with the headed screws in cases where the patient has poor bone quality.
Examples of small and long bone indications for which BITE Compression screws are used:
- Minimally invasive fracture/joint reconstructions
- Multiple-fragment joint fractures
- Simple epiphyseal fractures
- Fractures of the head of the humerus
- Fractures of the head of the tibia
- Cooper fractures of the tibia
- Fractures of the radius
- Fractures of the wrist, ankle, elbow and shoulder
- Scaphoid fractures and other fractures of the hand
- Metatarsal fractures and other fracture of the foot
- Ligament fixation of the proximal humerus
- Ligament avulsion injuries (Apohysis)
- Fractures of small joint bones
- Malleolar fractures
- Navicular fractures
- Fractures of the calcaneus and talus
- Arthrodesis of the ankle joint
- Avulsion fracture and metatarsal V
- Fractures of the tarsal region
- Osteotomies
BITE Compression Screws are not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The EDGE Orthopaedics BITE™ Compression Screws include sterile titanium self- drilling and self- tapping screws. The corresponding instrumentation (depth gauges, forceps, screwdrivers, retractors, and tenaculums) to facilitate insertion is found in EDGE's RIVAL™ Instrument Tray. The cannulated compression screws are offered in a variety of diameters and lengths designed for the temporary fixation, correction or stabilization of bones. The unique low profile head design, cutting characteristics and vast screw options of the BITE Compression Screws provides extensive versatility in one comprehensive system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones appropriate for the size of the device, humerus, tibia, radius, wrist, ankle, elbow, shoulder, scaphoid, hand, metatarsal, foot, proximal humerus, malleolar, navicular, calcaneus, talus, ankle joint, metatarsal V, tarsal region. Not intended for use in the spine.
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 safety and effectiveness of the EDGE Orthopaedics BITE™ Compression Screws are adequately supported by the substantial equivalence information, materials information and test results provided within this Premarket Notification. Clinical data was not used to determine substantial equivalence.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
5. 510(k) Summary
K132893 page 1 of 2
Date Prepared [21 CFR 807.92(a)(1)|
November 14, 2013
Submitter's Information [21 CFR 807.92(a)(1)]
Jan Triani EDGE Orthopaedics 6 Mars Court, Unit 6-3 Boonton, NJ 07005 Phone: (201)543-9388 Fax: (973)794-6813
Establishment Registration Number: TBD
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)|
| Trade Name: | EDGE Orthopaedics BITE™ Compression Screw |
|---|---|
| Common Name: | Bone Screw |
| Classification Name: | Class II, 21 CFR 888.3040, Product Code: HWC |
| Panel Code: | Orthopedics |
Predicate Device |21 CFR 807.92(a)(3)|
| WRIGHT TM Compression Screw (aka DART-FIRE®) | – K082320 (Wright Medical Technology) |
|---|---|
| DARCO® Headless Compression Screws | – K080850 (Wright Medical Technology) |
| DARCO® Headed Cannulated Screws | – K100359 (Wright Medical Technology) |
Description of the Device [21 CFR 807.92(a)(4)]
The EDGE Orthopaedics BITE™ Compression Screws include sterile titanium self- drilling and self- tapping screws. The corresponding instrumentation (depth gauges, forceps, screwdrivers, retractors, and tenaculums) to facilitate insertion is found in EDGE's RIVAL™ Instrument Tray. The cannulated compression screws are offered in a variety of diameters and lengths designed for the temporary fixation, correction or stabilization of bones. The unique low profile head design, cutting characteristics and vast screw options of the BITE Compression Screws provides extensive versatility in one comprehensive system.
Intended Use [21 CFR 807.92(a)(5)]
EDGE Orthopaedics' BITE™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. BITE Compression Screws are intended for single use only.
BITE Compression Screws are intended for use over a guide pin or wire. EDGE Orthopaedics' washers may be used with the headed screws in cases where the patient has poor bone quality.
1
K132893 page 2 of 2
Examples of small and long bone indications for which BITE Compression screws are used:
- Minimally invasive fracture/joint reconstructions o
- . Multiple-fragment joint fractures
- Simple epiphyseal fractures .
- Fractures of the head of the humerus o
- Fractures of the head of the tibia o
- o Cooper fractures of the tibia
- o Fractures of the radius
- Fractures of the wrist, ankle, elbow and shoulder .
- Scaphoid fractures and other fractures of the hand .
- . Metatarsal fractures and other fracture of the foot
- Ligament fixation of the proximal humerus .
- Ligament avulsion injuries (Apohysis) .
- Fractures of small joint bones
- o Malleolar fractures
- o Navicular fractures
- . Fractures of the calcaneus and talus
- Arthrodesis of the ankle joint �
- Avulsion fracture and metatarsal V .
- Fractures of the tarsal region .
- Osteotomies �
BITE Compression Screws are not intended for use in the spine.
Technological Characteristics [21 CFR 807.92(a)(6)]
The subject device is similar in design, material and indications to the predicate devices.
Performance Data [21 CFR 807.92(b)(1)]
The safety and effectiveness of the EDGE Orthopaedics BITE™ Compression Screws are adequately supported by the substantial equivalence information, materials information and test results provided within this Premarket Notification.
Clinical Data [21 CFR 807.92(b)(2)]
Clinical data was not used to determine substantial equivalence.
Conclusion |21 CFR 807.92(b)(3)]
The analysis of the EDGE Orthopaedics BITE™ Compression Screws within this Premarket Notification supports the conclusion that the subject device is as safe and effective as the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered horizontally and appears to be the heading of a document or webpage. The font is sans-serif and the color is black.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2013
ICON ORTHOPAEDIC CONCEPTS DBA EDGE ORTHOPAEDICS Ms. Jan Triani Director of Quality Assurance and Regulatory Affairs 6 Mars Court Unit 6-3 Boonton. New Jersey 07005
Re: K132893
Trade/Device Name: EDGE Orthopaedics BITE™ Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 7, 2013 Received: October 8, 2013
Dear Ms. Triani:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Jan Triani
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wigqins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use Statement
510(k) Number (if known): K132893 page 1 of 2
Device Name: EDGE Orthopaedics BITE™ Compression Screws
Indications for Use:
EDGE Orthopaedics' BITE™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. BITE Compression Screws are intended for single use only.
BITE Compression Screws are intended for use over a guide pin or wire. EDGE Orthopaedics' washers may be used with the headed screws in cases where the patient has poor bone quality.
Examples of small and long indications for which BITE Compression screws are used:
- Minimally invasive fracture/joint reconstructions ●
- Multiple-fragment joint fractures .
- Simple epiphyseal fractures .
- o Fractures of the head of the humerus
- Fractures of the head of the tibia o
- o Cooper fractures of the tibia
- Fractures of the radius O
- o Fractures of the wrist, ankle, elbow and shoulder
- Scaphoid fractures and other fractures of the hand .
- . Metatarsal fractures and other fracture of the foot
- . Ligament fixation of the proximal humerus
- Ligament avulsion injuries (Apohysis) o
- . Fractures of small joint bones
- o Malleolar fractures
- 0 Navicular fractures
- o Malleolar fractures
- . Fractures of the calcaneus and talus
- . Arthrodesis of the ankle joint
- Avulsion fracture and metatarsal V �
- . Fractures of the tarsal region
- Osteotomies .
BITE Compression Screws are not intended for use in the spine.
5
K132893 Page 2 of 2
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices