(87 days)
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
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.
STANDARD HBS™: 3.0mm shaft diameter, 4.7mm proximal thread diameter, 4.0mm distal thread diameter. 10mm through 30mm length in one millimeter increments.
The screws are made from titanium alloy.
The provided document is a 510(k) Premarket Notification Summary for the HBS™ Headless Bone Screw. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not available in these documents.
Here's a breakdown of the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify formal acceptance criteria for device performance in the context of a clinical study, as it's a 510(k) for substantial equivalence. The "performance" discussed is primarily in terms of biomechanical properties and material specifications, which are compared to predicate devices for equivalence.
| Feature/Characteristic | Acceptance Criteria (Not explicitly stated as such, but implied for equivalence) | Reported Device Performance |
|---|---|---|
| Biomechanical Testing | Not explicitly stated (implied to be similar to or better than predicate devices) | High Compression Mode: > 200N (in excess of values obtained with similar devices) Standard Compression Mode: 165N (in excess of values obtained with similar devices) |
| Material Compliance | ISO 5832-3:1996(E) | Device materials meet ISO 5832-3:1996(E). |
| Manufacturing Quality | ISO 9001-2000 regulations | Device produced according to ISO 9001-2000 regulations. |
| Sterilization Assurance Level (SAL) | At least 10^-6 for recommended cycle | Use of recommended sterilization cycle produces an SAL of at least 10^-6. |
| Intended Use | Substantially equivalent to predicate devices (Zimmer HBS™, Onyx Navicular) | Broader indications for use than Onyx device, but shares many with Zimmer HBS™. (See table in original document for full comparison). |
| Design | Substantially equivalent to predicate devices | Headless, threaded both ends, similar lengths and diameters to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" for performance evaluation in the way one would for an AI/diagnostic device. The biomechanical testing mentioned is likely laboratory-based. No patient-specific data or data provenance (country of origin, retrospective/prospective) is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in that sense. The "ground truth" for biomechanical performance would be the experimental measurements themselves.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical implant, not an algorithm.
7. The Type of Ground Truth Used
For the biomechanical testing, the "ground truth" is the empirically measured force values (e.g., 200N, 165N) obtained from testing the screws. For material and manufacturing, the ground truth is compliance with relevant ISO standards.
8. The Sample Size for the Training Set
Not applicable. No training set for an algorithm is mentioned in this document.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is mentioned.
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6 2002 JUN
020791/
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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.
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K020791
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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 .
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020791
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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.
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020791
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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.
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K020791
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Comparison Table:
| FEATURE | MMT HBS™ | Zimmer HBS™ | Onyx Navicular | SE? |
|---|---|---|---|---|
| Intended Use: | Scaphoid fracturesCarpal fractures & non-unionsCapitellum fracturesMetacarpal fracturesPhalangeal fracturesDistal radial fracturesRadial head fracturesUlnar styloid fracturesSmall joint fusionsHumeral head fracturesGlenoid fracturesIntercarpal fusionsInterphalangeal fracturesMetatarsal osteotomiesTarsal fusionsMalleolar fracturesPatellar fracturesOsteo-chrondral fracturesOdontoid fracturesMandibular 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.4.5mmDistal 4.0mm | Unknown | Yes |
| Design | Headless, Threaded both ends | Same | Same | Yes |
| Sterilization | Steam | Steam | Steam | Yes |
| K-Number | Pending | 792022 | 931681 | Yes |
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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.
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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
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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)
§ 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.