(88 days)
Multitak SS™ bone anchors are intended for use as a load bearing or nonload bearing suture anchor used in the attachment of soft tissue to bone in various orthopedic procedures.
Multitak SS™ bone anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:
Shoulder: Bankart lesion repairs, S.L.A.P. lesions repairs, Acromio-clavicular repairs, Capsular shift/capsulolabral reconstruction, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar or radial collateral ligament reconstruction, Extra-capsular repairs
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Posterior oblique ligament repair, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure, Medial/Lateral repairs/reconstructions
Foot/Ankle: Achilles tendon repairs, Midfoot and forefoot repairs, Hallus valgus reconstruction
Hand/Wrist: Collateral ligament repair (Gamekeeper's Thumb), Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Multitak SS™ bone anchors are cylindrical suture anchors with an overall ratio of approximately 2:1, length to diameter. The suture anchors are processed from human cortical bone and provided sterile and are intended for single use. The bone soft tissue anchors with attached suture are inserted into a predrilled bone hole site with a single use disposable or a reusable introduction device. The suture ends are pulled to engage cancellous bone and to toggle and lock the anchor in bony tissue. A curved needle attached to the suture end(s) is used to secure soft tissue to bone.
The provided text describes a 510(k) premarket notification for a medical device, the Multitak SSTM Bone Anchor. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance. The information requested (acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets) is typically associated with AI/ML device submissions or devices requiring clinical performance data for approval, which is not the case here.
However, based on the provided text, we can infer the "acceptance criteria" and "study" in the context of a 510(k) submission as demonstrating substantial equivalence to a predicate device through comparative performance testing on mechanical properties.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Device must perform equivalently to its predicate device in terms of mechanical properties (specifically pullout strength and failure modes) to demonstrate similar safety and effectiveness. | "Performance testing comparing the pullout strengths and failure modes of Multitak SSTMs cortical bone anchors to titanium anchors demonstrated that the anchors were statistically equivalent." The new Multitak SSTM Bone Anchor (cortical bone) demonstrated equivalent pullout strengths and failure modes to the predicate Multitak SSTM Titanium Anchor (K973015). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the performance testing comparing the new cortical bone anchor to the titanium predicate. It simply states "Performance testing."
- Data Provenance: The data is generated from in vitro performance testing (mechanical testing) of the physical devices, not from human or animal subjects. Details on the location of the testing are not provided. The data is prospective for this specific comparison study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This concept is not applicable here. Ground truth in this context would be objective physical measurements of mechanical properties (pullout strength, failure modes). These are determined by mechanical testing equipment and protocols, not by expert consensus.
4. Adjudication Method for the Test Set
- Not applicable. Mechanical testing results are quantitative and do not typically require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices or devices where human interpretation of medical data is involved. The Multitak SSTM Bone Anchor is a physical surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
- Objective Mechanical Measurements: The "ground truth" was established through direct
measurement of physical properties, specifically pullout strength and failure modes, using standardized mechanical testing methods relevant to surgical anchors.
8. The Sample Size for the Training Set
- Not applicable. This device doesn't involve an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this device.
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Bonutti Research, Inc. - Multitak SSTM Bone Anchor 510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: Patrick Balsmann, MS, RAC, Manager, OA & Regulatory/Clinical Affairs Bonutti Research, Inc., P.O. Box 1367, Effingham, Illinois 62401 Phone: 217.342.3412, ext. 321
Date Prepared: September 13, 1999
Proprietary Name: Multitak SSTM Bone anchor
Common Name: Soft Tissue Anchor
Classification Name: Unclassified.
Device Description: Multitak SS™ bone anchors are cylindrical suture anchors with an overall ratio of approximately 2:1, length to diameter. The suture anchors are processed from human cortical bone and provided sterile and are intended for single use. The bone soft tissue anchors with attached suture are inserted into a predrilled bone hole site with a single use disposable or a reusable introduction device. The suture ends are pulled to engage cancellous bone and to toggle and lock the anchor in bony tissue. A curved needle attached to the suture end(s) is used to secure soft tissue to bone.
Intended Use: The Multitak SS™ bone anchors are intended for use as load bearing or non-load bearing suture anchors in the attachment of soft tissue to bone in various orthopedic surgical procedures. The bone anchors are provided sterile and are intended for single use with suture up to USP Size No. 2.
Multitak SS™ bone anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:
- Shoulder: Bankart lesion repairs S.L.A.P. lesions repairs Acromio-clavicular repairs Capsular shift/capsulolabral reconstruction Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
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Bonutti Research, Inc. - Multitak SSTM Bone Anchor 510(k) Summary of Safety and Effectiveness Page 2
- Biceps tendon reattachment Elbow: Tennis elbow repair Ulnar or radial collateral ligament reconstruction Extra-capsular repairs Knee: Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure Medial/Lateral repairs/reconstructions Foot/Ankle: Achilles tendon repairs Midfoot and forefoot repairs Hallus valgus reconstruction Hand/Wrist: Collateral ligament repair (Gamekeeper's Thumb) Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction
Predicate Device: The Multitak SS™ bone anchors are similar in intended use and design to Multitak SS™ titanium suture anchors (K973015.) The bone anchors method of insertion with disposable or reusable introduction devices is similar in design and materials to currently marketed Multitak SS™ introduction devices (K973015 and K934183.) Performance testing comparing the pullout strengths and failure modes of Multitak SSTM cortical bone anchors to titanium anchors demonstrated that the anchors were statistically equivalent.
Predicate Comparison: A chart comparing characteristics of the Multitak SS™ bone anchors to those of the predicate devices is attached.
Submitted by:
Stryker Baker
Patrick Balsmann Manager, QA & Regulatory/Clinical Affairs
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Bonutti Research, Inc. - Multitak SSTM Bone Anchor 510(k) Premarket Notification Substantial Equivalence Chart
| Device Characteristic | Multitak SSTM Bone Anchor | Multitak SSTM Titanium Anchor | Multitak SSTM Stainless SteelAnchor |
|---|---|---|---|
| 510(k) Number | Current Submission. | K973015. | K934183. |
| Intended Use | Orthopedic procedures involvingthe attachment of soft tissue tobone. | Orthopedic procedures involvingthe attachment of soft tissue tobone. | Orthopedic procedures involvingthe attachment of soft tissue tobone. |
| Indications For Use | Shoulder, elbow, knee, foot/ankle,and hand/wrist soft tissue to boneorthopedic procedures. | Shoulder, elbow, knee, foot/ankle,and hand/wrist soft tissue to boneorthopedic procedures. | Shoulder, elbow, knee, andfoot/ankle soft tissue to boneorthopedic procedures. |
| Anchor Design | Cylindrical anchors approximateratio of 2:1 length to diameter. | Cylindrical anchors approximateratio of 2:1 length to diameter. | Tubular anchors approximate ratioof 2:1 length to diameter. Singleand double anchor tube constructs. |
| Anchor Material | Allograft human cortical bone. | Titanium. | Stainless steel. |
| Anchor InsertionMethod | Anchor with threaded sutureloaded on to tip of disposable orreusable introduction device. | Anchor with threaded sutureloaded on to tip of disposableintroduction device. | Anchor with threaded sutureloaded on to tip of reusableintroduction device. |
| Anchor ProvidedSterile | Sterile. | Sterile. | Sterile. |
| Anchor Packaging | One individual anchor preloadedin disposable introduction device.One individual anchor. | One individual anchor preloadedin disposable introduction device. | One individual anchor preloadedin disposable introduction device.One individual anchor. |
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 1999
Mr. Patrick G. Balsmann, MS, RAC Manager, QA & Regulatory/Clinical Affairs Bonutti Research, Incorporated P.O. Box 1367 2600 South Raney Effingham, Illinois 62401
Re: K993115
Trade Name: Multitak SSTM Bone Anchor Regulatory Class: II Product Code: MAI and JDW Dated: September 17, 1999 Received: September 20, 1999
Dear Mr. Balsmann:
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 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 requirement, as set forth in the Quality System Regulation (OS) 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.
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Page 2 - Mr. Patrick G. Balsmann, MS, RAC
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) 594-4659. 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" (21 CFR 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
hereely yours,
-ilme (l. H. Hage-
Xur James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Bonutti Research, Inc. – Multitak SSTM Bone Anchor 510(k) Premarket Notification
INDICATIONS FOR USE
Device Name: Multitak SSTM bone anchor.
Indications for Use: Multitak SS™ bone anchors are intended for use as a load bearing or nonload bearing suture anchor used in the attachment of soft tissue to bone in various orthopedic procedures.
Multitak SS™ bone anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:
| Shoulder: | Bankart lesion repairs |
|---|---|
| S.L.A.P. lesions repairs | |
| Acromio-clavicular repairs | |
| Capsular shift/capsulolabral reconstruction | |
| Deltoid repairs | |
| Rotator cuff tear repairs | |
| Biceps tenodesis | |
| Elbow: | Biceps tendon reattachment |
| Tennis elbow repair | |
| Ulnar or radial collateral ligament reconstruction | |
| Knee: | Extra-capsular repairs |
| Medial collateral ligament repair | |
| Lateral collateral ligament repair | |
| Posterior oblique ligament repair | |
| Illiotibial band tenodesis | |
| Patellar tendon repair | |
| VMO advancement | |
| Joint capsule closure | |
| Foot/Ankle: | Medial/Lateral repairs/reconstructions |
| Achilles tendon repairs | |
| Midfoot and forefoot repairs | |
| Hallus valgus reconstruction | |
| Hand/Wrist: | Collateral ligament repair (Gamekeeper's Thumb) |
| Scapholunate ligament reconstruction | |
| Tendon transfers in phalanx | |
| Volar plate reconstruction |
Prescription Use X
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K993115
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.