(20 days)
Not Found
No
The 510(k) summary describes a mechanical implant (cannulated screws) and does not mention any software, algorithms, or AI/ML capabilities. The focus is on the physical characteristics and intended use of the screws.
No
A therapeutic device is one that treats or manages a disease or condition. This device is used for fracture fixation, which is a supportive rather than a therapeutic function, helping in the healing process but not directly treating a disease or disorder.
No
The provided text describes a surgical implant system used for bone fracture fixation and similar orthopedic procedures, not for diagnosing medical conditions.
No
The device description clearly states that the device consists of physical components (cannulated screws and washers) made from a specific material (Biodur 108). This indicates a hardware-based medical device, not a software-only one.
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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (cannulated screws and washers) used for fixing bone fractures and performing osteotomies and arthrodesis. These are physical devices implanted into the body during surgery.
- Intended Use: The intended use clearly states the device is for "long and small bone fracture fixation" and lists specific anatomical locations and procedures. This is a therapeutic and structural function, not a diagnostic one based on in vitro analysis.
The description of the device and its intended use aligns with a Class II or Class III medical device used in orthopedic surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:
- Fractures of the tarsals and metatarsals;
- Metatarsal and phalangeal osteotomies;
- Fractures of the carpals and metacarpals;
- Carpal and metacarpal arthrodesis;
- Small fragments of the hand and wrist;
- Ligament fixation, if appropriate;
- Sacroiliac joint disruptions;
- Fractures of the distal femur and proximal tibia;
- Intracapsular fractures of the hip;
- Ankle arthrodesis; and
- Pelvis and acetabulum fractures; and
- Areas where accurate screw placement is vital.
This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.
Product codes (comma separated list FDA assigned to the subject device)
HWC, OUR
Device Description
The Cannulated Screw System by Pioneer consists of cannulated screws of varying diameters, thread configurations, and lengths to accommodate variations in surgical technique, severity level of fracture, and differing patient anatomy. The screws are available in self-tapping or self-drilling, in partially and fully threaded configurations, in diameters ranging from 3.5mm – 7.5mm and lengths ranging from 8-200mm. The system also includes correspondingly sized washers, the use of which is optional. The purpose of this submission is to extend the available screw lengths to 200mm. The screws and washers are manufactured from Biodur 108 (ASTM F2229).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long and small bone fracture fixation, which may include: tarsals, metatarsals, phalangeal, carpals, metacarpals, hand, wrist, sacroiliac joint, distal femur, proximal tibia, hip, ankle, pelvis, acetabulum. Not indicated 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)
Engineering calculations were also provided to demonstrate that under a worst-case bending situation, additional length of screw will not raise new issues of safety or effectiveness.
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.
K003496 – Pioneer Cannulated Screw System, K021932 – Synthes 6.5mm Cannulated Screw, K962011 - Synthes 7.0/7.3mm Cannulated Screw
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
Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'k', followed by the numbers '102903'. The handwriting style is cursive, with some connections between the characters. The image appears to be a close-up of the handwritten sequence.
510(k) SUMMARY
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・ . "
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Pioneer Cannulated Screw System
| Sponsor: | Manufacturer | Pioneer Surgical Technology
375 River Park Circle
Marquette, MI 49855 | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------|
| | Official Contact:
Phone:
Fax: | Emily M. Downs
(906) 225-5602
(906) 226-4459 | OCT 2 0 2010 |
| | Date prepared: | October 20, 2010 | |
| Device Name: | Pioneer Cannulated Screw System | | |
| Classification
Name: | The classification of the Pioneer Cannulated Screw System is Class II, as per the Code
of Federal Regulations, Title 21:
21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener.
21CFR 888.3030: Single/multiple component metallic bone fixation appliances and
accessories | | |
| Product Code: | Product Code: HWC: Screw, Fixation, and HTN: washer, bolt nut
The Panel code is 87. | | |
| Predicate
Device: | K003496 – Pioneer Cannulated Screw System (SE 02/08/2001)
K021932 – Synthes 6.5mm Cannulated Screw (SE 9/6/2002)
K962011 - Synthes 7.0/7.3mm Cannulated Screw (SE 8/5/1996) | | |
| Description: | The Cannulated Screw System by Pioneer consists of cannulated screws of varying
diameters, thread configurations, and lengths to accommodate variations in surgical
technique, severity level of fracture, and differing patient anatomy. The screws are
available in self-tapping or self-drilling, in partially and fully threaded configurations,
in diameters ranging from 3.5mm – 7.5mm and lengths ranging from 8-200mm. The
system also includes correspondingly sized washers, the use of which is optional.
The purpose of this submission is to extend the available screw lengths to 200mm. | | |
| | and washers are manufactured from Riodur 108 (ASTM F2229) | | |
The screws and washers are manufactured from Biodur 108 (ASTM F2229)
. . . .
R. 1 of 2.
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区102903
| Intended Use: | The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following: | ||
|---|---|---|---|
| 1. Fractures of the tarsals and metatarsals; |
- Metatarsal and phalangeal osteotomies;
- Fractures of the carpals and metacarpals;
- Carpal and metacarpal arthrodesis;
- Small fragments of the hand and wrist;
- Ligament fixation;
- Sacroiliac joint disruptions;
- Fractures of the distal femur and proximal tibia;
- Intracapsular fractures of the hip;
- Ankle arthrodesis;
- Pelvis and acetabulum fractures; and
- Areas where accurate screw placement is vital. | | |
| Material: | This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer may be offered both sterile and non-sterile and is a single use device.
The Pioneer Cannulated Screw System is composed of the identical material to the predicate Pioneer Cannulated Screw System, Biodur 108 (ASTM F2229). | | |
| Comparison to Predicate Devices: | The subject device has indication for use, material (Biodur 108), screw diameter (7.0/7.5mm), and mechanism of action identical to the Pioneer Cannulated Screw System (K003496). The subject device has the same maximum length (200mm) as the Synthes Cannulated Screw (K021932). | | |
| Non-Clinical Performance Data: | Engineering calculations were also provided to demonstrate that under a worst-case bending situation, additional length of screw will not raise new issues of safety or effectiveness. | | |
| Performance and SE Determination: | Based on the supporting documentation within this premarket notification, the subject device demonstrates substantial equivalence to the listed predicate devices. | | |
6-22662
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
APR 1 5 2011
Pioneer Surgical Technology, Inc. % Emily M. Downs Regulatory Affairs Project Manager 375 River Park Circle Marquette, Michigan 49855
Re: K102903
Trade/Device Name: Pioneer Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, OUR Dated: September 29, 2010 Received: September 30, 2010
Dear Ms. Downs:
This letter corrects our substantially equivalent letter of October 20, 2010.
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, listing 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.
3
Page 2 - Emily M. Downs
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
Aiz B. A. for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
2903 K10
Device Name:
Cannulated Screw System
Indications:
The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:
-
- Fractures of the tarsals and metatarsals;
-
- Metatarsal and phalangeal osteotomies;
-
- Fractures of the carpals and metacarpals;
-
- Carpal and metacarpal arthrodesis;
-
- Small fragments of the hand and wrist:
-
- Ligament fixation, if appropriate;
-
- Sacroiliac joint disruptions;
-
- Fractures of the distal femur and proximal tibia;
-
- Intracapsular fractures of the hip;
-
- Ankle arthrodesis; and
-
- Pelvis and acetabulum fractures; and
-
- Areas where accurate screw placement is vital.
This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.
OR
Prescription Use V (Per 21 CFR 801.109)
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _1
for M. Melkerson
Division Sign. Vision of Surgicil. Orthopedic, Division of Restorative Devices
510(k) Number K102903