(87 days)
Not Found
No
The summary describes a mechanical bone screw system and its intended use, materials, and performance testing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a bone screw system intended for the fixation of osseous fragments or fractures, which is a therapeutic purpose to aid healing and restore function.
No
This device is a bone screw system intended for the fixation of osseous fragments or fractures; it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a system of cannulated bone screws made from titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a "Headless bone screw system" made of titanium alloy, intended for the "fixation of osseous fragments or fractures." This is a surgical implant used directly within the body to stabilize bones.
- Intended Use: The intended use clearly states the device is for fixing fractures and fusions in various bones. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
The description of this device aligns with a surgical implant or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
Headless bone screw system for the fixation of osseous fragments or fractures including:
HBS - MINI
Scaphoid fractures
Lunate fractures
Capitate
Trapezial fractures
Metacarpal and metatarsal fractures
Phalangeal fractures
Radial head fractures
Ulnar styloid fractures
Osteo-chrondral
Small joint fusions
HBS - STANDARD
Scaphoid fractures
Carpal fractures & non-unions
Capitellum fractures
Metacarpal fractures
Phalangeal fractures
Distal radial fractures
Radial head fractures
Ulnar styloid fractures
Small joint fusions
Humeral head fractures
Glenoid fractures
Intercarpal fusions
Interphalangeal fractures
Metatarsal osteotomies
Tarsal fusions
Malleolar fractures
Patellar fractures
Osteo-chrondral fractures
Odontoid fractures
Mandibular fractures
Product codes
HWC
Device Description
The HBS™ (Headless Bone Screw) and the mini HBS™ are supplied as two series of cannulated bone screws varying in length and diameter. Both systems are intended for small bone applications and are thus considered a single system. Indeed, both systems are intended for use primarily in the hands and feet. The systems may be used for selected fractures elsewhere in the body so long as medically indicated and bone mass compatible.
Available screws and instrumentation are available as two individually boxed sets offered in the following sizes:
MINI HBS™
1.5mm shaft diameter, 3.2mm proximal thread diameter, 2.5mm distal thread diameter.
10mm through 30mm length in one millimeter increments.
Instrumentation:
Handle for drill guide
Drill guide
Drill
Drill handle
T-Drive screw driver
MBS Tray Mini
STANDARD HBS™
3.0mm shaft diameter, 4.7mm proximal thread diameter, 4.0mm distal thread diameter.
10mm through 30mm length in one millimeter increments.
Instrumentation:
Guide wire, 1mm
Guiding handle for drill guide
Drill guide
Measuring sleeve
Cannulated drill
Cortical Drill
Tap, standard compression
Tap, high compression
Cleaning wire
Wire Dispencer
Drill handle
T-Drive screw driver
Reduction Sleeve
MBS Tray Standard
Container 300 x 300 x 140
MMT supplies instrumentation designed specifically to interface with this implant system. Drawings of necessary specialized instruments are included in Appendix II with the system engineering drawings.
The screws are made from titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands, feet, scaphoid, lunate, capitate, trapezial, metacarpal, metatarsal, phalangeal, radial head, ulnar styloid, carpal, capitellum, distal radial, proximal humerus, glenoid, intercarpal, interphalangeal, tarsal, malleolar, patellar, odontoid, mandibular.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician only.
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)
Fixation characteristics of the screws were determined in both high compression and low compression modes. High compression mode vielded values in excess of 200N. Standard compression mode yielded values of 165N. In both instances, these values are in excess of values obtained with similar devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
6 2002 JUN
020791/
page 1 of 5
December 14.
510(k) Premarket Notification Summary of Safety and Effectiveness Information
Device Name:
Trade Name: Common Name: Classification Name:
HBS™ Headless Bone Screw
Bone Screw Smooth & threaded metallic bone fixation fasteners
Establishment Name & Registration Number:
Millennium Medical Technologies, Inc. (MMT) Name: Number: Pending
Classification:
ProCode: HWC
Performance Standards (Section 514 compliance):
Food and Drug Administration mandated Performance standards for bone screws are not in effect. MMT intends to comply with all voluntary Performance Standards applicable to the HBS™ Headless Bone Screw system.
At the present time, The device is produced according to ISO 9001-2000 regulations covering medical devices. In addition, the materials used to construct the device meet ISO-5832-3,1996(E).
Special Controls:
All Class II devices are subject to Special Controls. No FDA mandated special controls are in effect at the present time.
Labeling:
The labeling of the device includes the following statements:
Federal (United States) Law restricts this device to sale by or on the order of a Warning: physician only.
CAUTION: Mixing of dissimilar metals can accelerate the corrosion process, The components of this system must NOT be used with implants of other material composition. Components of the HBS™ Headless Bone Screw should NOT be used with screws or components from any other system or manufacturer.
Equivalent Device(s):
HBS™ Headless Bone Screw may be directly contrasted with the following equivalent devices:
The Zimmer HBS is essentially identical (clinically speaking) to the HBS™ Headless Bone Screw in terms of basic design, features and intended use. The Onyx device is also very similar in design except that the Onyx device is indicated only for Navicular fractures, where as the MMT device has broader indications for use.
1
K020791
page 2 of 5
Description of the Device:
The HBS™ (Headless Bone Screw) and the mini HBS™ are supplied as two series of cannulated bone screws varying in length and diameter. Both systems are intended for small bone applications and are thus considered a single system. Indeed, both systems are intended for use primarily in the hands and feet. The systems may be used for selected fractures elsewhere in the body so long as medically indicated and bone mass compatible.
Available screws and instrumentation are available as two individually boxed sets offered in the following sizes:
MINI HBS™
- 1.5mm shaft diameter, 3.2mm proximal thread diameter, 2.5mm distal thread ● diameter.
- 10mm through 30mm length in one millimeter increments. .
Instrumentation:
- Handle for drill guide .
- . Drill guide
- Drill
- . Drill handle
- . T-Drive screw driver
- MBS Tray Mini .
STANDARD HBS™
- 3.0mm shaft diameter, 4.7mm proximal thread diameter, 4.0mm distal thread . diameter.
- 10mm through 30mm length in one millimeter increments. ●
Instrumentation:
- Guide wire, 1mm ◆
- Guiding handle for drill guide ●
- . Drill guide
- Measuring sleeve
- Cannulated drill .
- . Cortical Drill
- . Tap, standard compression
- . Tap, high compression
- . Cleaning wire
- . Wire Dispencer
- Drill handle .
- T-Drive screw driver
- Reduction Sleeve
- MBS Tray Standard .
- Container 300 x 300 x 140 .
2
020791
page 3 of 5
Intended Use: MINI
- Scaphoid fractures ●
- . Lunate fractures
- Capitate .
- Trapezial fractures ●
- Metacarpal and metatarsal fractures ●
- Phalangeal fractures .
- . Radial head fractures
- Ulnar styloid fractures ●
- Osteo-chrondral ●
- Small joint fusions ●
Intended Use: STANDARD
- Scaphoid fractures t
- Carpal fractures & non-unions .
- . Capitellum fractures
- Metacarpal fractures .
- Phalangeal fractures .
- . Distal radial fractures
- Radial head fractures .
- Ulnar styloid fractures .
- � Small joint fusions
- . Humeral head fractures
- . Glenoid fractures
- Intercarpal fusions .
- Interphalangeal fractures .
- Metatarsal osteotomies .
- Tarsal fusions .
- Malleolar fractures .
- Patellar fractures .
- Osteo-chrondral fractures .
- . Odontoid fractures
- Mandibular fractures .
MMT supplies instrumentation designed specifically to interface with this implant system. Drawings of necessary specialized instruments are included in Appendix II with the system engineering drawings.
The screws are made from titanium alloy. Material standard(s) are as specified in the table below:
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Summary of Biomechanical Testing:
Fixation characteristics of the screws were determined in both high compression and low compression modes. High compression mode vielded values in excess of 200N. Standard compression mode yielded values of 165N. In both instances, these values are in excess of values obtained with similar devices.
3
020791
page 4 of 5
Applicant / Sponsor Name / Address:
Millennium Medical Technologies, Inc. 460 St. Michaels Drive, Suite 901 Santa Fe, New Mexico, 87505 505.988.7595 -- 505.988.7234 fax
Contact Person:
Mr. Fred Kolb Millennium Medical Technologies, Inc. 460 St. Michaels Drive, Suite 901 Santa Fe, New Mexico, 87505 505.988.7595 - 505.988.7234 fax
Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 fax
Manufacturing Facility:
At the present time, the devices are contract manufactured in Europe and will be imported into the United States. The contract manufacturer is a recognized, registered manufacturer of implantable medical devices. The HBS screws are manufactured for MMT for distribution in the U.S.A.
Performance Standards:
There are no applicable FDA mandated performance standards for this device. However, voluntary standards such as ASTM, various in-house Standard Operating Procedures and vendor qualification procedures are in place and utilized in the production of the screws.
St rilization, Packaging & Storage Information:
Sterilization. The HBS™ Headless Bone Screws and instruments are provided non-sterile and must be sterilized prior to use. The devices are clean and have been processed to remove debris and manufacturing residue.
The recommended sterilization process for the instruments is high temperature steam autoclave sterilization. The recommended sterilization cycle is: saturated steam at 270° F for 30 minutes. This is a typical or usual steam sterilization cycle used by hospitals for surgical devices and instruments. Use of this cycle produces a Sterility Assurance Level (SAL) of at least 10-6. Validation of the recommended sterilization cycle is completed. The following validated sterilization cycle is on file at MMT.
| Method: | Steam |
|---|---|
| Cycle: | Gravity |
| Temperature: | 270°F (134°C) |
| Exposure Time: | 30 minutes |
Packaging. Materials used in the production of the device are typical medical grade tubes, peel-type pouches of the generic mylar/non-woven sandwich variety, etc. All packages containing implants or instruments should be intact upon receipt.
4
K020791
page 5 of 5
Comparison Table:
| FEATURE | MMT HBS™ | Zimmer HBS™ | Onyx Navicular | SE? |
|---|---|---|---|---|
| Intended Use: | Scaphoid fractures | |||
| Carpal fractures & non-unions | ||||
| Capitellum fractures | ||||
| Metacarpal fractures | ||||
| Phalangeal fractures | ||||
| Distal radial fractures | ||||
| Radial head fractures | ||||
| Ulnar styloid fractures | ||||
| Small joint fusions | ||||
| Humeral head fractures | ||||
| Glenoid fractures | ||||
| Intercarpal fusions | ||||
| Interphalangeal fractures | ||||
| Metatarsal osteotomies | ||||
| Tarsal fusions | ||||
| Malleolar fractures | ||||
| Patellar fractures | ||||
| Osteo-chrondral fractures | ||||
| Odontoid fractures | ||||
| Mandibular fractures | Same | Navicular | Yes | |
| Materials | Titanium | Same | Same | Yes |
| Lengths | 10-30 mm in 1mm increments | 10-30mm, 2mm | 10-30mm | Yes |
| Diameters | Proximal thread 4.7mm (S) | |||
| Proximal thread 3.2mm (M) | ||||
| Distal thread 4.0mm (S) | ||||
| Distal thread 2.5mm (M) | ||||
| Shaft Dia. 3.0mm (S) | ||||
| Shaft Dia. 1.5mm (M) | Prox.4.5mm | |||
| Distal 4.0mm | Unknown | Yes | ||
| Design | Headless, Threaded both ends | Same | Same | Yes |
| Sterilization | Steam | Steam | Steam | Yes |
| K-Number | Pending | 792022 | 931681 | Yes |
5
Image /page/5/Picture/1 description: The image contains the words "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged on a single line, with "Public Health" appearing before "Service".
Image /page/5/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol of medicine and healing, with three intertwined snakes wrapped around a staff.
6 2002 אחר
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Millennium Medical Technologies, Inc c/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane Suite C-100 Pleasant Hill, CA 94523-3389
Re: K020791
Trade/Device Name: HBS™ Headless Bone Screw Regulatory Number: 888.3040 Regulatory Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 7, 2002 Received: March 11, 2002
Dear Mr. Schlerf:
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.
6
Page 2 - Mr. David W. Schlerf
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). 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.
Mach N Millhinn
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
HBS™ Headless Bone Screw Device Name:
Indications For Use:
Headless bone screw system for the fixation of osseous fragments or fractures including:
| HBS - MINI | HBS - STANDARD |
|---|---|
| Scaphoid fractures | Scaphoid fractures |
| Lunate fractures | Carpal fractures & non-unions |
| Capitate | Capitellum fractures |
| Trapezial fractures | Metacarpal fractures |
| Metacarpal and metatarsal fractures | Phalangeal fractures |
| Phalangeal fractures | Distal radial fractures |
| Radial head fractures | Radial head fractures |
| Ulnar styloid fractures | Ulnar styloid fractures |
| Osteo-chrondral | Small joint fusions |
| Small joint fusions | Humeral head fractures |
| Glenoid fractures | |
| Intercarpal fusions | |
| Interphalangeal fractures | |
| Metatarsal osteotomies | |
| Tarsal fusions | |
| Malleolar fractures | |
| Patellar fractures | |
| Osteo-chrondral fractures | |
| Odontoid fractures | |
| Mandibular fractures |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark A. Mellone
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K020791
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _ (Optional format 1-2-96)