(75 days)
HEALOS® Fx Injectable Bone Graft Replacement ("HEALOS Fx"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may he surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS Fx is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
The HEALOS® Fx Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® Fx Injectable Bone Graft Replacement to a surgical site.
HEALOS Fx Injectable Bone Graft Replacement is a mineralized collagen matrix processed into lyophilized fibrous material for surgical implantation. The principal components of the HEALOS Fx Injectable Bone Graft Replacement are Type I bovine collagen and hydroxyapatite. HEALOS Fx is approximately 20-30% mineral by weight.
The HEALOS Fx Graft Mixing and Delivery System is designed to facilitate the mixing of autogenous bone marrow aspirate with the HEALOS Fx material and to deliver this bone graft mixture into the surgical site. Included in the kit are two chambers: a mixing chamber and a delivery chamber.
The provided text is related to a 510(k) premarket notification for a medical device called HEALOS® Fx Injectable Bone Graft Replacement and its associated Mixing and Delivery System. This document is a regulatory submission to the FDA, primarily focusing on establishing substantial equivalence to predicate devices for market clearance.
As such, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.
The "Performance Data" section explicitly states: "No performance standards have been established for this type of device." This indicates that the regulatory pathway for this device did not require a study with quantitative performance metrics against pre-defined acceptance criteria for the purpose of this 510(k) submission. Instead, the focus is on a comparison to existing legally marketed devices.
Therefore, I cannot provide the requested information from this document.
{0}------------------------------------------------
K081758
(pg. 1 of 2)
510(K) SUMMARY 5.
| Submitter: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767 | SEP - 3 2008 |
|---|---|---|
| Contact Person: | Hande TufanSr. Regulatory Affairs AssociateVoice: (508) 828-3065Fax: (508) 828-3797E-Mail: ftufanya@dpyus.jnj.com | |
| Date Prepared: | June 19, 2008 | |
| Device Class: | Class II | |
| HEALOS® Fx DeviceClassification Name: | Resorbable calcium salt bone void filler§888.3045 | |
| HEALOS® Fx GraftMixing and DeliverySystem Classification Name: | Piston Syringe§880.5860 | |
| Classification Panel: | Orthopedic | |
| FDA Panel Number: | 87 | |
| Product Code(s): | MQV and FMF | |
| Proprietary Name: | HEALOS® Fx Injectable Bone Graft ReplacementHEALOS® Fx Graft Mixing and Delivery System | |
| Predicate Devices:(Material) | HEALOS® Bone Graft Substitute (K012751 and K043308)HEALOS® Fx Bone Graft Substitute (K062495) | |
| (Mixing/Delivery device) | HEALOS® Fx Graft Mixing and Delivery System(K062495)Symphony® Graft Delivery System (K003286)Harvest® Graft Delivery System (K043261)Imbibe® II Syringe (K030208) | |
| Device Description: | HEALOS Fx Injectable Bone Graft Replacement is amineralized collagen matrix processed into lyophilizedfibrous material for surgical implantation. The principalcomponents of the HEALOS Fx Injectable Bone GraftReplacement are Type I bovine collagen andhydroxyapatite. HEALOS Fx is approximately 20-30%mineral by weight. | |
| The HEALOS Fx Graft Mixing and Delivery System isdesigned to facilitate the mixing of autogenous bonemarrow aspirate with the HEALOS Fx material and todeliver this bone graft mixture into the surgical site.Included in the kit are two chambers: a mixing chamber anda delivery chamber. | ||
| Intended Use: | HEALOS® Fx Injectable Bone Graft Replacement("HEALOS Fx"), combined with autogenous bone marrowis intended for use in filling bony voids or gaps of theskeletal system (i.e., the extremities, spine, and pelvis) thatare not intrinsic to the stability of the bony structure. Thesedefects may be surgically created osseous defects orosseous defects resulting from traumatic injury to the bone.The product provides a bone void filler that is resorbed andremodeled into new bone as part of the natural healingprocess. | |
| The HEALOS® Fx Graft Mixing and Delivery System isindicated for the mixing and delivery of HEALOS FxInjectable Bone Graft Replacement to a surgical site. | ||
| Materials: | The principal components of HEALOS Fx Injectable BoneGraft Replacement are Type I bovine collagen andhydroxyapatite. | |
| The principal components of the HEALOS Fx GraftMixing and Delivery System are copolymer and plasticmaterials. | ||
| Performance Data: | No performance standards have been established for thistype of device. |
.
{1}------------------------------------------------
{2}------------------------------------------------
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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2008
Dupuy Spine, Inc. % Mr. Hande Tufan Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K081758
Trade/Device Name: HEALOS® Fx Injectable Bone Graft Replacement HEALOS® Fx Graft Mixing and Delivery System Regulation Number: 21 CFR 888.3045 Regulation Names: Resorbable calcium salt bone void filler device. Regulatory Class: II Product Code: MQV, FMF Dated: June 19, 2008 Received: June 20, 2008
Dear Mr. Tufan:
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 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.
{3}------------------------------------------------
Page 2 - Mr. Hande Tufan
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE STATEMENT 4.
081758 510(k) Number (if known):
Device Name: HEALOS® Fx Injectable Bone Graft Replacement HEALOS® Fx Graft Mixing and Delivery System
HEALOS® Fx Injectable Bonc Graft Replacement Indications For Use:
HEALOS® Fx Injectable Bone Graft Replacement ("HEALOS Fx"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may he surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS Fx is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
HEALOS® Fx Graft Mixing and Delivery System Indications for Use:
The HEALOS® Fx Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® Fx Injectable Bone Graft Replacement to a surgical site.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
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)
Division of General, Restorative, and Neurological Devices
510(k) Number K081385
DePuy Spine, Inc. Traditional 510(k) Submission
§ 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.