SPRYTIE, MODELS ST001, ST002 AND ST003

K092530 · Russell B. Walther · DZK · Apr 2, 2010 · Dental

Device Facts

• Record ID: K092530
• Device Name: SPRYTIE, MODELS ST001, ST002 AND ST003
• Applicant: Russell B. Walther
• Product Code: DZK · Dental
• Decision Date: Apr 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Sprytie™ wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together (maxillomandibular fixation).

Device Story

Sprytie™ is a surgical fixation wire system consisting of 25, 26, or 27 gauge annealed 316L stainless steel wire (7 inches long) with a 304 stainless steel sleeve crimped onto one end. Used by clinicians in dental/oral surgery settings for maxillomandibular fixation, arch bar/splint placement, and intraosseous wiring. The sleeve provides stiffness to prevent wire flexure during insertion around teeth. The device replaces traditional light gauge surgical wire spools, offering improved ease of use through its pre-formed sleeve design. It functions as a mechanical fixation aid to stabilize bony segments or teeth.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: 316L stainless steel wire (25, 26, 27 gauge) and 304 stainless steel sleeve (22TW, 23TW, 24TW). Form factor: 7-inch wire with crimped sleeve. Principle: Mechanical fixation via wire tensioning. No software or energy source.

Indications for Use

Indicated for adults and children requiring maxillomandibular fixation, stabilization of bony segments in the jaw, or fixation of arch bars/splints to teeth.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• Aragon Wiring System (K022821)
• Erich Arch Bar (K061271)

Submission Summary (Full Text)

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K092530

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## 510(k) Summary

807.92(c)

Sponsor

APR - 2 2010

807.92(a)(1)

Submitter Russell Walther 6026 Martel Avenue Dallas, Texas 75206

Contact Person: Russell Walther Telephone: [phone] Fax: [phone]

Date Prepared: August 10, 2009

#### Device Name

807.92(a){2)

| Proprietary Name: | Sprytie™ (models ST001, ST002, ST003) |
|--------------------|-------------------------------------------------------------------------|
| Common/Usual Name: | Stainless Steel Wire for Maxillary and<br>Mandibular Fixation |
| Classification: | Class II<br>Dental Classification Panel<br>Wire, Fixation, Intraosseous |
| Regulation Number: | 872.4880 |
| Product Code: | DZK |

#### Predicate Devices

807.92(a)(3)

| Predicate Device #1: | Aragon Wiring System, K022821 |
|----------------------|-------------------------------|
| Predicate Device #2: | Erich Arch Bar, K061271 |

#### Device Description

# 807.92(a){4)

The Sprytie™ is a 25, 26, or 27 gauge annealed 316L stainless steel wire 7 inches in length, with a hollow 22TW, 23TW, or 24TW sieeve crimped over one end of the wire, respectively.

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A.K092530

The Sprytie™ is used in place of traditional light gauge stainless steel surgical wire during the placement of arch bars and splints, direct intraosseous wiring, bridal wire placement, and direct maxillomandibular fixation (ivy loops, risden wires, etc.). The sleeve end is inserted around the teeth first. The stiffness of the sleeve prevents the flexure of the wire.

#### Device Intended Use

Sprytie™ wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together (maxillomandibular fixation).

#### Device Technological Characteristics

The wire component of the Sprytie™ is identical to predicate devices. The Sprytie™ includes a ¾ inch 304 stainless steel sleeve crimped over one end. In predicate devices the wire is packaged in 75-675 ft length reusable spools. The predicate devices do not contain the 304 stainless steel portion.

#### Conclusion

The Sprytie™ has the same intended use as predicate devices, as well as substantially equivalent technical specifications. The modification to a traditional 316L stainless steel wire with the addition of a 304 stainless steel sleeve improves the ease of use of the wire, and does not change the intended use of the wire. The Sprytie™ is as safe, as effective, and performs as well as or better than predicate devices.

## 807.92(b)(3)

807.92(a)(6)

## 807.92(a)(5)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# APR - 2 2010

Mr. Russell B. Walther Russell B. Walther 6026 Martel Avenue Dallas, Texas 75206

Re: K092530

Trade/Device Name: Sprytie™M Regulation Number: 21CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZK Dated: March 18, 2010 Received: March 24, 2010

Dear Mr. Walther:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2- Mr. Walther

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hn for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Sprytie™

Indications for Use:

Sprytie™ wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together (maxillomandibular fixation).

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

rrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Orvision of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: