PEBA ANCHOR/SUTURE COMBINATION

K972326 · Orthopaedic Biosystems, Ltd. · MBI · Feb 6, 1998 · Orthopedic

Device Facts

• Record ID: K972326
• Device Name: PEBA ANCHOR/SUTURE COMBINATION
• Applicant: Orthopaedic Biosystems, Ltd.
• Product Code: MBI · Orthopedic
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures. The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency. The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications: Shoulder: 1. Bankart lesion repairs 2. SLAP lesion repairs 3. Acromio-clavicular separation repairs 4. Rotator cuff tear repairs 5. Capsular shift or capsulolabral reconstructions 6. Biceps tenodesis 7. Deltoid repairs Foot and Ankle: 1. Hallux Valgus repairs 2. Medial or lateral instability repairs/reconstructions 3. Achilles tendon repairs/reconstructions 4. Midfoot reconstructions 5. Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand: 1. Scapholunate ligament reconstructions 2. Ulnar or radial collateral ligament reconstructions 3. Tennis elbow repair 4. Biceps tendon reattachment Knee: 1. Extra-capsular repairs: a. medial collateral ligament b. lateral collateral ligament c. posterior oblique ligament 2. Iliotibial band tenodesis 3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

Device Story

Pre-packaged sterile device consisting of titanium alloy (TI6Al4VELI) suture anchor, stainless steel inserter, and braided polyester (poly(ethylene terephthalate)) suture. Used by surgeons in clinical/OR settings to secure soft tissue to bone. Surgeon prepares site with drill, uses inserter to screw anchor into bone, then removes inserter, leaving anchor and suture in situ. Tension between anchor and suture holds soft tissue to bone. Benefits include secure fixation for various orthopedic repairs and bladder neck suspension. No software or electronic components.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design comparisons to legally marketed predicate devices.

Technological Characteristics

Anchor: Titanium alloy (TI6Al4VELI). Inserter: 300/400 series or 17Cr-4Ni stainless steel. Suture: Braided multifilament poly(ethylene terephthalate) (USP requirements). Design: Screw-type anchor with hexagonal inserter interface. Sterile, single-use, manual mechanical device.

Indications for Use

Indicated for fixation of non-absorbable synthetic sutures in orthopedic procedures (shoulder, foot/ankle, elbow/wrist/hand, knee) and bladder neck suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Regulatory Classification

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.

Predicate Devices

• Zimmer's Statak 2.5 (K972326)
• Arthrex's Corkscrew 5.0 (K972326)

Submission Summary (Full Text)

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K972326

## 510 (k) SUMMARY - SAFETY and EFFECTIVENESS

Submitted by: Jeffrey P. Baldwin Orthopaedic Biosystems Limited, Incorporated 15990 N. Greenway-Hayden Loop, Suite 100 Scottsdale, AZ 85260 Phone: [phone]

Contact: Jeffry B. Skiba, Vice President of Engineering & Manufacturing

Date of preparation: October 1, 1997

Name: Anchor/Suture Combination Proprietary Name: PeBA Anchor/Suture Combination, Cinch Anchor/Suture Combination Common or usual name: Anchor/Suture Combination Regulatory Class: Class II

Since this submission deals with suture anchor of varying size, each size must be compared to legally marketed devices of reasonably equivalent size. See table on page 2 of this packet.

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6 1998

FEB

| Proposed Device | Equivalent Device |
|-------------------------|-------------------------|
| PeBA S 2.8 mm Anchor | Zimmer's Statak 2.5 |
| PeBA C 4.0 mm Anchor | Arthrex's Corkscrew 5.0 |
| PeBA RCR 5.0 mm Anchor* | Arthrex's Corkscrew 5.0 |
| PeBA C 6.8 mm Anchor | Arthrex's Corkscrew 5.0 |

The proposed device, Anchor/Suture Combination is a pre-packaged, sterile device composed of a suture anchor, anchor inserter, and non-absorbable sutures. The device shall be used to secure soft tissue to bone. The device is pre-packaged so that the suture is looped through the anchor eyelet and the anchor/suture is installed in the inserter. The anchor implant site shall be prepared with an appropriate OBL drill. The inserter is used to screw the anchor into the implant site. After the anchor is fully seated, the inserter is removed from the implant site, leaving the anchor in the bone and suture looped through the anchor.

All OBL anchors are marketed through K951451. The proposed device uses these 510K approved anchors and has identical Indications For Use as the S10K approved anchors.

The suture used in the proposed device is a braided polyester suture provided by Surgical Specialties and is currently market through N80950.

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The scientific basis for the device includes that the anchor is constructed as a screw with a means for suture to be secured to the thread body. When the threads are fully seated and the suture is secured to soft tissue, the anchor and suture shall be in tension to hold the soft tissue to the bone.

The proposed device is constructed from the following materials. The anchor is made of titanium alloy TI6Al4VELI. The suture is multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture meeting USP requirements. The inserter shaft is a 300 series, 400 series, 17Cr-4Ni, or other alloy stainless steel.

Please find the two attached "Package Inserts." OBL's anchors are marketed two ways. anchors for bladder neck suspension procedures, and anchors for orthopaedic uses other than bladder neck suspension procedures. The anchors marketed for bladder neck suspension procedures are sold under the name, Cinch™. The anchors that are marketed for orthopaedic procedures other than bladder neck suspension procedures are sold under the name, PeBA Series. Likewise, the anchor/suture combination will be sold as separate devices: The Cinch™ anchor/suture combination for bladder neck suspensions and the PeBA anchor/suture combination for the following indications:

### Indications For Use:

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.

The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphinctor deficiency.

The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:

### Shoulder:

- 1. Bankart lesion repairs
- 2. SLAP lesion repairs
- 3. Acromio-clavicular separation repairs
- 4. Rotator cuff tear repairs
- 5. Capsular shift or capsulolabral reconstructions
- 6. Biceps tenodesis
- 7. Deltoid repairs

### Foot and Ankle:

- 1. Hallux Valgus repairs
- 2. Medial or lateral instability repairs/reconstructions
- 3. Achilles tendon repairs/reconstructions
- 4. Midfoot reconstructions
- 5. Metatarsal ligament/tendon repairs/reconstructions

### Elbow, Wrist, and Hand:

- 1. Scapholunate ligament reconstructions
pp

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- 2. Ulnar or radial collateral ligament reconstructions in
- 3. Tennis elbow repair
- 3. Tennis cloow repair.
4. Biceps tendon reattachment

Knee:

res m

- 1. Extra-capsular repairs:
- medial collateral ligament a.
- lateral collateral ligament b.
- posterior oblique ligament C.
- 2. Iliotibial band tenodesis
- 2. Iliotibial band tenodesis
3. Patellar realignment and tendon repairs, including vastus medialis obliquous
- advancement

Following are tables of comparison and contrass between the PeBA Anchors and the f
or and the mail and institution table on page 2 of this packet. Following are tables of Companses and con page 2 of this packet.

| | PeBA S 2.8 mm Anchor | Zimmer Statak 2.5 Anchor |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | | |
| Anchor material | Titanium | Titanium |
| Inserter material | Stainless Steel | Stainless Steel |
| Suture material | Braided Polyester | Braided Polyester |
| Method of insertion | Inserter/anchor interface<br>hexagonal. Inserter turned<br>to screw anchor into bone. | Inserter/anchor interface<br>hexagonal. Inserter turned to<br>screw anchor into bone. |
| Basic construction of<br>inserter | A hardened stainless steel<br>shaft contains the<br>hexagonal receptacle for<br>the anchor head. The<br>shaft is cannulated to<br>contain the suture. | A hardened stainless steel tip<br>is fit into the shaft. The tip<br>contains the hexagonal<br>receptacle for the anchor<br>head. The tip and shaft are<br>cannulated to contain the<br>suture. |

| | BA S 2.8 mm Anchor compared to the Zimmer Statak 2.5 | |
|--|------------------------------------------------------|--|
|--|------------------------------------------------------|--|

| | D-BA S 2 8 mm Anchor contrasted to the Zimmer Statak 2.5 | | |
|--|----------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | and the program of the program of the program and to finance of the first of the first of the first of the first of the first of the first of the first of the first of the fi |

| Characteristic | PeBA S 2.8 mm Anchor | Zimmer Statak 2.5 Anchor |
|----------------------------|------------------------------------------------------|---------------------------------|
| Number of included sutures | 1 or 2 | 1 |
| Size of included suture | USP #2, #1, #0, #2-0 | USP #0 |
| Thread design | Double lead (“Hi-Lo” thread design). No drill means. | Single lead with a drill means. |
| Thread diameter | 2.8 mm | 2.5 mm |

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| Characteristic | PeBA C 4.0 mm Anchor compared to the Arthrex Corkscrew<br>PeBA C 4.0 mm Anchor | Arthrex Corkscrew 5.0 mm<br>Anchor |
|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anchor material<br>Inserter material<br>Suture material<br>Method of insertion<br>Basic construction of<br>inserter | Titanium<br>Stainless Steel<br>Braided Polyester<br>Inserter/anchor interface<br>hexagonal. Inserter turned<br>to screw anchor into bone.<br>A hardened stainless steel<br>shaft contains the<br>hexagonal receptacle for<br>the anchor head. The<br>shaft is cannulated to<br>contain the suture. | Titanium<br>Stainless Steel<br>Braided Polyester<br>Inserter/anchor interface<br>hexagonal. Inserter turned to<br>screw anchor into bone.<br>A hardened stainless steel<br>shaft contains the hexagonal<br>receptacle for the anchor<br>head. The shaft is cannulated<br>to contain the suture. |

## ared to the Arthrex Corkscrew 5.0 mm

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## PeBA C 4.0 mm Anchor contrasted to the Arthrex Corkscrew 5.0 mm

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| PeBA C 4.0 mm Anchor contrasted to the Arthrex Corkscrew 5.0 mm | | |
|-----------------------------------------------------------------|-----------------------------------------------------|---------------------------------|
| Characteristic | PeBA C 4.0 mm Anchor | Arthrex Corkscrew 5.0 mm Anchor |
| Number of included sutures | 1 or 2 | 2 |
| Size of included suture | USP #5, #2, #1, #0 | USP #2 |
| Thread design | Double lead (“Hi-Lo” thread design) No drill means. | Single lead with a drill means. |
| Thread diameter | 2.8 mm | 2.5 mm |

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| Characteristic | PeBA C 6.5 mm Anchor | Arthrex Corkscrew 5.0 mm Anchor |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Anchor material | Titanium | Titanium |
| Inserter material | Stainless Steel | Stainless Steel |
| Suture material | Braided Polyester | Braided Polyester |
| Method of insertion | Inserter/anchor interface<br>hexagonal. Inserter turned<br>to screw anchor into bone. | Inserter/anchor interface<br>hexagonal. Inserter turned to<br>screw anchor into bone. |
| Basic construction of<br>inserter | A hardened stainless steel<br>shaft contains the<br>hexagonal receptacle for<br>the anchor head. The<br>shaft is cannulated to<br>contain the suture. | A hardened stainless steel<br>shaft contains the hexagonal<br>receptacle for the anchor<br>head. The shaft is cannulated<br>to contain the suture. |

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## ists the Arthrex Corkscrew 5.0 mm

# BA C 6.5 mm Anchor contrasted to the Arthrex Corkscrew 5.0 mm

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| Characteristic | PeBA C 6.5 mm Anchor | Arthrex Corkscrew 5.0 mm Anchor |
|----------------------------|-----------------------------------------------------|---------------------------------|
| Number of included sutures | 1 or 2 | 2 |
| Size of included suture | USP #5, #2, #1, #0 | USP #2 |
| Thread design | Double lead (“Hi-Lo” thread design) No drill means. | Single lead with a drill means. |
| Thread diameter | 2.8 mm | 2.5 mm |

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Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the head, body, and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 1998

Mr. Jeffrey B. Skiba ·Vice President of Engineering Orthopaedic Biosystems Limited, Inc. 7320 East Butherus, Suite 206 85260 Scottsdale, Arizona

Re: K972326 PeBA Anchor/Suture Combination Requlatory Class: II Product Codes: JDR and MBI Dated: January 6, 1998 Received: January 9, 1998

Dear Mr. Skiba:

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 The general controls provisions of the Act 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 Requlations, 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 (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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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. Jeffrey B. Skiba

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

Cellia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix D: Indications for Use

### 510(k) Number (if known): K972326

vice Name: PEBA ANCHOR SUTURE COMBINATION

### Indications For Use:

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.

The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female unnary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The PeBA Series Anchor/Sulure Combination is intended for the fixation of surgical suture material for the following indications:

#### Shoulder: 1. Bankart lesion repairs SLAP lesion repairs 2. /300/H803/ Acromio-clavicular separation repairs 3. 4. Rotator cuff tear repairs ર. Capsular shift or capsulolabral reconstructions 6. Biceps tenodesis 7. Deltoid repairs Foot and Ankle: Hallux Valgus repairs 1. Medial or lateral instability repairs/reconstructions 2. Achilles tendon repairs/reconstructions 3. 4. Midfoot reconstructions 5. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

- 1. Scapholunate ligament reconstructions
- 2. Ulnar or radial collateral ligament reconstructions
- Tennis elbow repair 3.
- 4. Biceps tendon reattachment

### Knee:

- 1. Extra-capsular repairs:
- a. medial collateral ligament
- lateral collateral ligament b.
- posterior oblique ligament C.
- 2. Iliotibial band tenodesis
- 3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OI

A co
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K472326

Prescription Use: Y 21 CFR 801.109)

OR

Over-The-Counter Use:

(Optional Format 1-2-96)