(78 days)
Not Found
No
The device description and intended use focus solely on a physical, bioabsorbable suture anchor and its mechanical function in orthopedic surgery. There is no mention of software, algorithms, data processing, or any capabilities that would suggest the use of AI or ML.
Yes
The device is described as stabilizing damaged soft tissue in conjunction with appropriate postoperative immobilization throughout the healing period, which aligns with the definition of a therapeutic device.
No
The device is a suture anchor, a surgical implant used to reattach soft tissue to bone, not to diagnose a condition.
No
The device description clearly states it is a physical, bioabsorbable suture anchor made of poly-L/D-lactide copolymer, provided with sutures, a driver, and a drill bit. This is a hardware device, not software.
Based on the provided information, the Bionx Impact™ Suture Anchor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "reattach soft tissue to bone in orthopaedic surgical procedures." This is a surgical implant used directly on the patient's body.
- Device Description: The description details a physical implant (suture anchor) made of bioabsorbable material, preloaded with sutures, and used with a driver and drill bit. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Bionx Impact™ Suture Anchor is a therapeutic device used to repair tissue within the body.
N/A
Intended Use / Indications for Use
The Bionx Impact™ Suture Anchor is a bioabsorbale screw-in suture anchor that is preloaded on a disposable inserter device with two non-absorbable, braided, polyester #2 sutures. The Impact™ Suture Anchor is manufactured from Self-Reinforced (96/4D) PLA Copolymer that retains 90% strength through 20 weeks and completely resorbs over a period of several years in vivo. The unique Self-Reinforced Copolymer provides high initial mechanical strength required for insertion and through the healing phase (20 weeks) with complete absorption occurring over several years. The unique absorption profile of the Copolymer allows the anchor to gradually loose strength as the collagen fibres of the repair form and gain strength. The Copolymer is inert, non-collagenous and non-pyrogenic through the absorption process. The Impact™ Suture Anchor is indicated for use in arthroscopic or open surgical procedures to reattach soft tissue to the bone.
The Bionx Impact™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The Bionx Impact™ Suture Anchor is contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, osteoporotic, comminuted bone, pathologic conditions in the soft tissues to be attached, etc., 3) Conditions that may retard healing (poor blood supply, past or potential infection, etc), 4) Active infection, 5) Conditions that may limit the patients ability or willingness to restrict activities or follow directions during the healing period, 6) Foreign body sensitivity to materials, 7) Patients with suspected or known allergy with implant or suture materials.
Product codes
MAI, HWC
Device Description
Impact™ Suture Anchor is a smooth, cylindrical/conical shape, bioabsorbable, pushin suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Colour of green suture is D&C Green No 6, white suture represents original colour of polyester suture. Diameter of the anchor is 3.5mm and length 10.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a drill bit. The Impact™ Suture Anchor is made of poly-L/D-lactide copolymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopaedic surgical procedures, arthroscopic or open surgical procedures
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)
K020056, K972783, K973849, K992567, K003970, K001378, K013057, K990361, K990987, K003227, K990340, K973381, K992458, K984490, K963396, K960555, K964805, K963369, K983186, K990110, K950272, K970896, K964013, K911837, K964921
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary Bionx Implants Inc. Impact™ Suture Anchor
Submitter's Name, Address, Telephone Number, and Contact Person
Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Blue Bell, PA 19422
Contacts:
Gerard S. Carlozzi President and Chief Executive Officer Phone: (215) 643-5000 (215) 653-0984 Facsimile:
Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland Phone: 358-3-316 5679 Facsimile: 358-3-316 5629
January 28, 2003 Date prepared:
Name of the device:
| A. | Trade or Proprietary Name: | Impact ™ Suture Anchor |
|---|---|---|
| B. | Common Name: | Bioabsorbable suture anchor |
| C. | Classification Name: | Biodegradable soft tissue fixation fastener (87MAI) |
| D. | Device Product Code: | MAI |
| E. | Regulatory Classification: | Class II |
Predicate Device:
The Impact™ Suture Anchor is intended for use in the reattachment of soft tissue to bone by arthroscopy or direct visualization. This indication is substantial equivalent with Bionx Implants Inc. Duet™ Suture Anchor (K020056), SmartAnchor
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1
(K972783), Bankart Tack (K973849), Contour Labral Nail (K992567, K003970), BioCuff™ (K001378) and BioCuff™ C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio-Absorbable Corkscrew Suture Anchor (K990987), Bio-Absorbable CorkScrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K973381), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K990110), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle Anchor (K964013), Acufex Inc. Suretac 6.0, 8,0 (K911837) and DePuy Inc. De Puy Dupont Phantom Suture Anchor (K964921).
Intended Use:
The Bionx Impact™ Suture Anchor is a bioabsorbale screw-in suture anchor that is preloaded on a disposable inserter device with two non-absorbable, braided, polyester #2 sutures. The Impact™ Suture Anchor is manufactured from Self-Reinforced (96/4D) PLA Copolymer that retains 90% strength through 20 weeks and completely resorbs over a period of several years in vivo. The unique Self-Reinforced Copolymer provides high initial mechanical strength required for insertion and through the healing phase (20 weeks) with complete absorption occurring over several years. The unique absorption profile of the Copolymer allows the anchor to gradually loose strength as the collagen fibres of the repair form and gain strength. The Copolymer is inert, non-collagenous and non-pyrogenic through the absorption process. The Impact™ Suture Anchor is indicated for use in arthroscopic or open surgical procedures to reattach soft tissue to the bone.
The Impact™ Suture Anchor is contraindicated in the following conditions:
- Surgical procedures other than those listed. 1.
- Conditions that may compromise Anchor fixation (osteopenic, comminuted 2. bone, pathologic conditions in the soft tissues to be attached, etc.)
- Conditions that may retard healing (poor blood supply, past or potential 3. infection, etc).
-
- Active infection.
- Conditions that may limit the patients ability or willingness to restrict న్. activities or follow directions during the healing period.
- Foreign body sensitivity to materials. 6.
- Patients with suspected or known allergy to the implant or suture materials. 7.
Device Description:
Impact™ Suture Anchor is a smooth, cylindrical/conical shape, bioabsorbable, pushin suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Colour of green suture is D&C Green No 6, white suture represents original colour of polyester suture. Diameter of the anchor is 3.5mm and length 10.5mm. It is assembled with sutures
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with needles into single use, sterile, disposable driver and packaged into blister with a drill bit. The Impact™ Suture Anchor is made of poly-L/D-lactide copolymer. The poly-L/D-lactide material equals the raw material used in previously cleared Bionx Implants Inc. Duet™ Suture Anchor (K020056), SmartNail™ (K993074), Meniscus Arrow™ (K993453), SmartScrew ACL™ (K993073), SmartScrew (K012001), The Wedge™ (K000616), Contour Labral Nail (K003970), BioCuff (K001378) and BioCuff C (K013057).
Substantial Equivalence:
All of these devices have the same intended use and principles of operation and very similar technological characteristics. Furthermore, the minor technological differences between the Bionx Implants Inc. Impact™ Suture Anchor and the predicate devices do not raise any new issues of safety or effectiveness.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three wavy lines representing the feathers.
Public Health Service
APR 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants Ltd. Hermiankatu 6-8 L FIN-33720 Tampere Finland
Re: K030388
Trade/Device Name: Impact™ Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 28, 2003 Received: February 5, 2003
Dear Ms. Annala:
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.
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 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); good manufacturing practice requirements as set
4
Page 2 - Ms. Tuija Annala
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. 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) 594-4639. 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 may be obtained 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,
Miriam C. Provost
(W 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
5
INDICATIONS FOR USE
510(K) Number (if known): K030388
Device Name:
Impact™ Suture Anchor
Indications for Use:
The Bionx Impact™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The Bionx Impact™ Suture Anchor is contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, osteoporotic, comminuted bone, pathologic conditions in the soft tissues to be attached, etc., 3) Conditions that may retard healing (poor blood supply, past or potential infection, etc), 4) Active infection, 5) Conditions that may limit the patients ability or willingness to restrict activities or follow directions during the healing period, 6) Foreign body sensitivity to materials, 7) Patients with suspected or known allergy with implant or suture materials.
(Please do not write below this line - continue on another page is needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use
uriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030388