LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW

K021522 · Walter Lorenz Surgical, Inc. · DZL · May 21, 2002 · Dental

Device Facts

• Record ID: K021522
• Device Name: LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: DZL · Dental
• Decision Date: May 21, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Lactosorb® Tap Free Screw is indicated for use in the following midface and craniofacial procedures. - A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications: - Comminuted fractures of the naso-ethmoidal infraorbital areas 1. - Comminuted fractures of the frontal sinus wall 2. - Pediatric midface or craniofacial trauma 3. - 4. LeFort (I, II, II) fractures - 5. Orbital floor fractures - 6. Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. - Trauma of the craniofacial skeleton including: frontal, parietal, 7. temporal, sphenoid, and occipital bones. - B. General Indication: reconstructive procedures of the midface or craniofacial Skeleton - 1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.) - 2. LeFort (1, II, II, II) osteotomies - 3. Tumor reconstruction in midface or craniofacial procedures - 4. Bone graft procedures in the midface or craniofacial skeleton - 5. Pediatric reconstructive procedures - Reconstructive procedures of the craniofacial skeleton including: 6. frontal, parietal, temporal, sphenoid, and occipital bones - 7. Craniotomy flap fixation This system is not designed for use in the mandible and/or full load bearing procedures.

Device Story

Resorbable bone screw; 1.5 mm x 4 mm dimensions; composed of 82% L-Lactide/18% Glycolide copolymer. Device features non-threaded pin portion, head, and helical groove on major diameter. Implanted via rotation into pre-drilled hole smaller than major diameter; fixation achieved through press-fit mechanism. Used by surgeons in clinical settings for midface/craniofacial skeletal fixation. Provides temporary stabilization of bone fragments during healing; material degrades via hydrolysis into lactic and glycolic acids, then metabolized via Krebs cycle. Benefits include elimination of secondary removal surgery due to resorbable nature.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design, material, and functional comparison to predicate devices.

Technological Characteristics

Resorbable copolymer (82% L-Lactide/18% Glycolide); 1.5 mm x 4 mm dimensions; helical groove design; press-fit fixation; non-metallic; sterile.

Indications for Use

Indicated for pediatric and adult patients undergoing midface and craniofacial trauma repair or reconstructive surgery, including craniosynostosis, congenital malformations, tumor reconstruction, bone grafting, and craniotomy flap fixation. Contraindicated for use in the mandible or full load-bearing procedures.

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

• Lactosorb® 1.5 x 4 mm Direct Drive Screw (K971870)
• Lactosorb® Push Screws (K002423)

Reference Devices

• Lactosorb® bone plates (K992355, K992158, K971870, K960988, K955729)
• Lactosorb® bone screws (K981666, K960988)

Submission Summary (Full Text)

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MAY 2 1 2002

K021520

## Summary of Safety and Effectiveness

## Lorenz Lactosorb® 1.5 mm x 4 mm Tap Free Screw

Walter Lorenz Surgical, Inc. Submitter: 1520 Tradeport Drive Jacksonville, Florida 32218-2480

Establishment Registration: 1032347

Contact Person: Sheryl Malmberg Regulatory Affairs (904)-741-4400

Trade Name: Lorenz 1.5 x 4 mm Lactosorb® Tap Free Screw

Common or Usual Name: Resorbable Bone Screw

Classification Name: Screw, Fixation, Intraosseous (21 CFR 872.4880)

Device Classification: Class II

Device Product Code: DZL

Indications for Use:

The Lactosorb® Tap Free Screw is indicated for use in the following midface and craniofacial procedures.

- A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:
- Comminuted fractures of the naso-ethmoidal infraorbital areas 1.
- Comminuted fractures of the frontal sinus wall 2.
- Pediatric midface or craniofacial trauma 3.
- 4. LeFort (I, II, II) fractures
- 5. Orbital floor fractures
- 6. Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones.
- Trauma of the craniofacial skeleton including: frontal, parietal, 7. temporal, sphenoid, and occipital bones.

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- B. General Indication: reconstructive procedures of the midface or craniofacial Skeleton
- 1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
- 2. LeFort (1, II, II, II) osteotomies
- 3. Tumor reconstruction in midface or craniofacial procedures
- 4. Bone graft procedures in the midface or craniofacial skeleton
- 5. Pediatric reconstructive procedures
- Reconstructive procedures of the craniofacial skeleton including: 6. frontal, parietal, temporal, sphenoid, and occipital bones
- 7. Craniotomy flap fixation

This system is not designed for use in the mandible and/or full load bearing procedures.

Device Description: The device is a screw having a non-threaded pin portion and a head portion. The Lactosorb® Tap Free Screw is designed with a slight helical groove that is cut into the major diameter. The head geometry, drive mechanism, major diameter, and tip geometry of the 1.5 x 4 mm Tap Free Screw is identical to that of the 1.5 x 4 mm Direct Drive Screw (K971870). The only difference between the two screws is the "thread" form.

Although the tap free screws are similar in design to the standard Lactosorb® direct drive screws (K971870), they function more like the Lactosorb® Push Screws (K002423). The push screws are designed with barbs that are pushed into a drilled hole that is slightly smaller than the diameter around the barbs. This press fit holds the push screw is place and provides adequate fixation. The tap-free screws are implanted by rotating the screws into a hole that is slightly smaller than the major diameter of the screws. The press fit between the implant and the hole provides the fixation.

Material: Lactosorb® (resorbable copolymer) - a polyester derivative of lactic and glycolic acids

Lactosorb® is made of 82% L-Lactide/18% Glycolide copolymer that degrades by hydrolysis into L-Lactic and glycolic acids. These hydrolytic products are then further degraded into carbon dioxide and water via the cellular Krebs cycle. Lactosorb® has been previously cleared by 510(k) notifications for use in bone plates (K992355, K992158, K971870, K960988, K955729) and bone screws (K002423, K981666, K960988) for cranial and maxillofacial use.

The modifications made to this device are not anticipated to significantly affect its safety and effectiveness.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

21 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sheryl Malmberg Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218-2480

Re: K021522

Trade/Device Name: Lorenz 1.5 mm x 4.0 mm Lactosorb® Tap Free Screw Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: Class II Product Code: DZL Dated: May 08, 2002 Received: May 10, 2002

Dear Ms. Malmberg:

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.

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#### Page 2 - Ms. Sheryl Malmberg

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. or the Fee of all , I 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 and inoms (2) roquiceller as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 110(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 [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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dspamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS FOR USE

510(k) Number K021522

Device Name: Lorenz 1.5 mm x 4mm Lactosorb® Tap Free Screw

#### Indications for Use:

The Lactosorb® Tap Free Screw is indicated for use in the following midface and craniofacial procedures.

- A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:
- 1. Comminuted fractures of the naso-ethmoidal infraorbital areas
- 2. Comminuted fractures of the frontal sinus wall
- 3. Pediatric midface or craniofacial trauma
- 4. LeFort (1, II, II) fractures
- 5. Orbital floor fractures
- 6. Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones.
- 7. Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones.
- B. General Indication: reconstructive procedures of the midface or craniofacial Skeleton

Specific Indications:

- 1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
- 2. LeFort (I, II, II) osteotomies
- 3. Tumor reconstruction in midface or craniofacial procedures
- 4. Bone graft procedures in the midface or craniofacial skeleton
- 5. Pediatric reconstructive procedures
- 6. Reconstructive procedures of the craniofacial skeleton including: frontal. parietal, temporal, sphenoid, and occipital bones
- 7. Craniotomy flap fixation

This system is not designed for use in the mandible and/or full load bearing procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

~~SORRump~~ OR Over-The-Counter-Use
(Division Sign-Off) ~~(Optional Format 1-2-96) ~~
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K021522

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