(90 days)
Wright Medical Technology's OsteoSet® Pellets
Not Found
No
The description focuses on the material composition and physical properties of calcium sulfate pellets used as a bone void filler. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a bone void filler that aids in the healing process by resorbing and being replaced by bone, which is a therapeutic function.
No
This device, Synthes Calcium Sulfate Pellets, is described as a bone void filler that resorbs and is replaced with bone during the healing process. Its purpose is therapeutic (filling bony voids), not diagnostic (identifying or detecting a condition).
No
The device is a physical implantable material (calcium sulfate pellets) and not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "bone void filler" for bony voids or gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition and physical properties of the pellets, which are designed to be implanted into the body to aid in bone healing. This is consistent with a medical device used for treatment or repair, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is directly implanted into the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Synthes Calcium Sulfate Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Pellets are to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the Pellets are biodegradable and biocompatible, they may be used at an infected site.
Product codes (comma separated list FDA assigned to the subject device)
87 MQV
Device Description
Synthes Calcium Sulfate Pellets are composed of a porous, osteoconductive, bone void filler material consisting of calcium sulfate dihydrate and stearic acid. When used according to directions, the biodegradable, radiopaque pellets are resorbed in approximately 30 - 60 days and replaced by natural bone.
The cylindrical pellets weigh approximately 100 mg and are supplied in capped, glass vials in sizes of 50, 100 and 200 pellets per vial. The product is pre-sterilized by gamma radiation and is not intended to be resterilized. It is for single use only.
Synthes Calcium Sulfate Pellets have the same dissolution rate, compression strength and mass to volume ratio characteristics as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system including the extremities, spine, and pelvis.
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)
Not Found
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.
Wright Medical Technology's OsteoSet® Pellets
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
§ 888.3045 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.
0
NOV = 1 2000
510(k) Summary
Sponsor
Device Name
Classification
Predicate Device
Device Description
Intended Use
Material
Synthes (USA) 1690 Russell Road Paoli, PA 19301 Bonnie Smith (610) 647-9700
Synthes (USA) Calcium Sulfate Bone Void Filler Pellets
Unclassified. The Device Product Code is 87 MQV.
Wright Medical Technology's OsteoSet® Pellets
Synthes Calcium Sulfate Pellets are composed of a porous, osteoconductive, bone void filler material consisting of calcium sulfate dihydrate and stearic acid. When used according to directions, the biodegradable, radiopaque pellets are resorbed in approximately 30 - 60 days and replaced by natural bone.
The cylindrical pellets weigh approximately 100 mg and are supplied in capped, glass vials in sizes of 50, 100 and 200 pellets per vial. The product is pre-sterilized by gamma radiation and is not intended to be resterilized. It is for single use only.
Synthes Calcium Sulfate Pellets have the same dissolution rate, compression strength and mass to volume ratio characteristics as the predicate device.
Synthes Calcium Sulfate Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The pellets are to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the pellets are biodegradable and biocompatible, they may be used at an infected site.
Calcium Sulfate
Synthes (USA) Calcium Sulfate Bone Void Filler Pellets
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, graphic style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV = 1 2000
Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, PA 19301
Re: K002362
Synthes Calcium Sulfate Pellets Regulatory Class: unclassified Product Code: MQV Dated: August 2, 2000 Received: August 3, 2000
Dear Ms. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Bonnie J. Smith
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Mark N. Mullens
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
3
Indications for Use Statement 2.
Page ot
510(k) Number (if known):
Device Name:
Indications:
K002362
Synthes (USA) Calcium Sulfate Bone Void Filler Pellets
Synthes Calcium Sulfate Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Pellets are to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the Pellets are biodegradable and biocompatible, they may be used at an infected site.
Contraindications:
This product is not intended to provide structural support during the healing process; therefore, Synthes Pellets are contraindicated in cases where structural support of the skeletal system is required.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
for Mark N Milburn
(Division Sign-Off)
Division of General Restorative Devices 510(k) Number.
CONFIDENTIAL
Synthes (USA) Calcium Sulfate Bone Void Filler Pellets