(430 days)
The TRUREPAIR™ Bone Graft Substitute is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The TRUREPAIR™ Bone Graft Substitute is intended to be gently packed 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.
TRUREPAIR™ implants use the PolyGraft technology and are porous, resorbable scaffolds composed of polylactide-co-glycolide (PLG) copolymer and calcium sulfate. The copolymer is amorphous (noncrystalline) and resorbs in four to twelve months, depending on shape and location. The device also contains Polyglycolide (PGA) fibers and a surfactant.
The provided text is a 510(k) summary for the TRUREPAIR Bone Graft Substitute. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (PolyGraft BGS) through comparison of intended use, materials, available shapes, sizes, packaging, shelf life, and sterilization.
The summary states: "Performance testing conducted includes bench and animal studies that demonstrate substantial equivalence to the PolyGraft BGS." However, it does not provide details about these studies, such as their design, sample sizes, specific performance metrics, or results against any defined acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, or expert involvement, as these details are not present in the provided document.
The document indicates that the device's substantial equivalence is based on its similarity to a legally marketed predicate device, rather than a direct study demonstrating its performance against specific acceptance criteria.
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NOV 0 9 2007
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as
required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
TRUREPAIR BONE GRAFT SUBSTITUTE
Date Prepared: November 7, 2007
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Deana Boushell Principal Regulatory Specialist (508)337-4036
C. Device Name
Trade Name: TRUREPAIR™ Bone Graft Substitute Common Name: Bone Graft Substitute Classification Name: Resorbable calcium salt bone void filler device
D. Predicate Devices
The Smith & Nephew TRUREPAIR Bone Graft Substitute is substantially equivalent in Intended Use and Scientific Technology to the following legally marketed device in commercial distribution: K030288 PolyGraft BGS
E. Description of Device
TRUREPAIR™ implants use the PolyGraft technology and are porous, resorbable scaffolds composed of polylactide-co-glycolide (PLG) copolymer and calcium sulfate. The copolymer is amorphous (noncrystalline) and resorbs in four to twelve months, depending on shape and location. The device also contains Polyglycolide (PGA) fibers and a surfactant . See chart below for available shapes and sizes.
| Product Name | Shape | Size Range |
|---|---|---|
| TruGraft | Granules | 3 - 30 cc |
| TruFit | Plug | 3 – 11 mm diameter18mm length |
| TruBlock | Block | 15 - 25 mm width15 - 25 mm height10 - 20 mm length |
| TruWedge | Wedge | 5 - 15° angle5 mm-15mm height |
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F. Intended Use
The TRUREPAIR™ Bone Graft Substitute is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The tradina of surgery that are novels intended to be gently packed into bony voids or gaps I RONEI All< - Done Gran (i.e., the extremities, spine and pelvis). These defects may be surgically of the skerstan system (we sseous defects created from traumatic injury to the bone. The erculed obsociate a bone void filler that resorbs and is replaced with bone during the healing process.
| Polygraft BGS | TRUREPAIR | |
|---|---|---|
| Indications For Use | The Polygraft BGS is to be used to fillbony voids or gaps caused by trauma orsurgery that are not intrinsic to thestability of the bony structure. ThePolyGraftTM BGS is intended to begently packed into bony voids or gaps ofthe skeletal system (i.e., the extremities,spine and pelvis). These defects may besurgically created osseous defects orosseous defects created from traumaticinjury to the bone. The product providesa bone void filler that resorbs and isreplaced with bone during the healingprocess. | Same |
| Materials | polylactide-co-glycolide (PLG);Calcium Sulfate | Same |
| Available Shapes | Granules, cubes, blocks, wedges andsingle phase plugs | Granules, cubes, blocks,wedges and dual phase plugs |
| Available Sizes | Up to 15cc by volume | Same (See device descriptionfor available shapes & sizes) |
| Packaging/Shelf Life | PETG Tray w/ Tyvek Lid in Poly TyvekBag / 2 year shelf life | Same |
| Sterilization | EO | Same |
Comparison of Technological Characteristics ﻥ
Summary Performance Data H.
The currently marketed TruRepair Product line is substantially equivalent to the PolyGraft BGS. There have been no changes to indications for use, materials, shelf life, sterilization or packaging. Performance testing conducted includes bench and animal studies that demonstrate substantial equivalence to the PolyGraft BGS.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
Smith & Nephew, Inc. Endoscopy Division c/o Ms. Deana Boushell Principal Regulatory Specialist 150 Minuteman Rd. Andover. MA 01810
Re: K062607
Trade/Device Name: TRUREPAIR Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Regulatory Class: Class II Product Code: MQV Dated: August 10, 2007 Received: August 13, 2007
Dear Ms. Boushell:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
The safety and effectiveness of this device for use in osteochondral defects have not been established.
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Page 2 - Ms. Deana Boushell
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the I icase note that the a00700(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate I he I DA minding of saostanial for your device and permits your device to proceed to the device results in a clubsial on to begin marketing your device as described in your mance. "This reter will and ification if the limitation statement described above is added to vour labeling.
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 Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not I feast that FDA has made a determination that your device complies with other requirements mount that I Drima matures and regulations administered by other Federal agencies. or the ret of may 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 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D., M.P.A.
Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K062607
Device Name: TRUREPAIR Bone Graft Substitute
Indications For Use:
The TRUREPAIR™ Bone Graft Substitute is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The TRUREPAIR™ Bone Graft Substitute is intended to be gently packed 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.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vortm
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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.