K Number

Device Name

Manufacturer

DEPUY ORTHOPAEDICS, INC.

Date Cleared

2012-03-12

(272 days)

Product Code

HRS,HSB,HTN,HTY,HWC,JDW,KTT,LXT

Regulation Number

Type

Panel

Predicate For

Intended Use

The indications for use remain unchanged from the existing clearances.

TTC Fusion Nail:
Intended for use in intramedullary fixation of supracondylar fractures of the femur, including those with severe comminution and intraarticular involvement, osteoporosis, nonunions, malunions, pathologic and fractures proximal to total knee arthroplasty or prosthesis. The TTC Fusion Nail is also indicated for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement, absent talus (tibio calcaneal arthrodesis); post traumatic/primary arthrosis involving both ankle and subtalar joints; a rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total arthroplasty.
Intended for use in tibiocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Indications also include non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.

Small Bone Locked Plating System:
Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
For stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

Spider Plate:

Fixation of metaphyseal fractures of the distal tibia
Proximal metaphyseal tibial fractures
Calcaneus fractures
Proximal humeral head/shaft fractures
Distal femur fracture -- comminuted shaft fractures
Fixation of soft tissue, such as tendon and ligaments, to bone

Reconstruction & Straight Plate:
Small bone plates (3.5mm): For intra-articular distal tibial fractures and those of the humeral head; for fractures of the fibula, lateral malleolus, metatarsals and metacarpals, olecranon and distal humerus; for application to the palmar surface of the distal radius and fractures of the olecranon and distal tibia; for application to the dorsum of the distal radius; fractures of the calcaneus; fractures of the radius and ulna; for pelvic and acetabular reconstructive surgery
Large bone plates (4.5, 6.5mm): For use on the tibia, femur and humerus; for use on the anterior aspect of the distal tibia; for use as a tension band on the proximal humerus and as a buttress on the medial tibial plateau; for use as a buttress on the lateral tibial plateau; for use on fractures of the pelvis and acetabulum; for fractures of the distal humerus; for use as a tension band plate on the radius, ulna and fibula.

TiMax Medial Pilon Plate:
Pilon fractures: distal tibial intraarticular fractures, high medial malleolar fractures, low boot type rotational distal extraarticular shaft fractures.

TiMax Meta Plate:
Distal intra-articular tibia fractures; proximal tibia fractures; proximal and distal humerus fractures.

100 Degree Tubular Plate:
Fractures of the fibula, lateral malleolus, metatarsals and metacarpals, olecranon, distal humerus and humeral head; application to the dorsum of the distal radius; fractures of the radius and ulna; intra-articular distal tibial fractures.

Universal Reconstruction Plate:
The 3.5mm plate may be used for fractures of the clavicle, scapula, distal humerus, acetabulum and pelvis.
The 4.5mm plate is intended for use in the following types of fractures: pelvic fractures and acetabular fractures.

Anatomic Locked Plating System:
For fixation of fractures, fusions, osteotomies and non-unions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone.

Fracture and Fusion Plating System:
Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 – 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

LCL and Fusion Plating System:
Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Proximal Tibia Locking Plating System:
Intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures.

Sterile DVR:
Intended for fixation of fractures and osteotomies involving the distal radius.

Locking Anatomic and Composite Plating System:
For fixation of fractures, osteotomies and non-unions of the fibula, malleolus, metatarsals and metacarpais, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna and distal tibia, particularly in osteopenic bone.

Anterolateral and Medial Locking Plating System:
The Medial Locking Plate is indicated for pilon fractures: distal tibial intraarticular fractures, high medial malleolar fractures, low boot type rotational distal extraarticular shaft fractures.
The Anterolateral Locking Plates are indicated for distal intraarticular tibia fractures, proximal tibia fractures and proximal and distal humerus fractures.

Large Fragment Locking Plating System (Locking Broad and Narrow):
Fixation of various long bones, such as the humerus, femur and tibia. Also for use in fixation of osteopenic bone and fixation and stabilization of non-unions, malunions and osteotomies.

Small Fragment Locking Plating System:
Intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Fragment Plate System:
Intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton.

Polyax Locked Plating System:
Intended for use in cases requiring stabilization of malunions, non-unions, and osteotomies of the distal femur and proximal tibia and Open Reduction Internal Fixation (ORIF) repair of closed and open fractures of the distal femur and proximal tibia including, but not limited to the following: periarticular fractures, such as simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression fractures with associated shaft fractures, and periprosthetic fractures.

Multidirectional Threaded Peg:
Intended for the fixation of fractures and osteotomies involving the distal radius.

Distal Volar Radius Anatomical Plate System:
Intended for the fixation of fractures and osteotomies involving the distal radius.

PERI II Knee Fracture System:
Intended for use in fracture fixation cases requiring open reduction internal fixation (ORIF) for closed and open fractures of the distal femur and proximal tibia including repair of non-unions, malunions and fractures including but not limited to simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.

Calcaneal Peri-Articular Plate:
Designed to assist the surgeon in the management of intra-articular fractures of the calcaneus, extra-articular fractures of the calcaneus.

TK2 Hip Screw System:
Indicated for fractures of the proximal femur extending from the subcapital area to the level of the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgment surrounding each patient's particular situation.

Trochanteric Side Plate:
Internal fixation of hip fractures.

Supracondylar Plate:
Internal fixation of hip fractures.

Captured Hip Screw:
Internal fixation of hip fractures.

6.5mm Solid Cancellous Bone Screw:
Indications for use of this device shall include fixation of the pelvis and of the long bones, including the femur, tibia, ulna, radius, humerus and fibula.

8.0mm Cannulated Cancellous Bone Screw:
Fracture fixation of long bones (femur, tibia, subcapital fracture of the hip, pelvic ring, acetabulum, foot and ankle and os calcis, olecranon).

Titanium Mini-Plating System:
For plating of maxillofacial fractures or for other small bone fractures (fracture fixation) as determined by the surgeon.

Cannulated Cortical Bone Screw:
Fracture fixation of long bones.

Cannulated Self-tapping Cancellous Bone Screw:
Fracture fixation of long bones.

Cannulated Self-tapping Cortical Bone Screw:
General orthopaedic conditions and fractures that would benefit from the use of cannulated self-tapping cortical bone screws.

Cancellous Bone Screw:
Internal fixation of hip fractures and for additional orthopaedic indications such as condylar fractures of the distal femur and/or selected fractures of the tibial plateau.

Diaphyseal Plate:
Intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, fibula, particularly osteopenic bone.

Shoulder Fixation System:
Intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus.

Cannulated Bone Screw:
Intended for use over a guide pin for fracture fixation in cancellous bone. The cannulated screw is intended to be inserted into pre-drilled bone.

Tibial Nail:
Intended for bone fixation in the management of fracture and reconstructive surgeries.
Non-weight bearing bone fixation is indicated in the following conditions:

Transverse, oblique, spiral, segmental and comminuted fractures;
Fractures with bone loss and bone transport;
Open fractures, pathologic fractures;
Corrective osteotomies;
Pseudarthrosis of the tibial shaft;
Nonunions, malunions, metaphyseal and epiphyseal fractures.

Washer:
Intended to be used in conjunction with bone screws.

Trochanteric Nail:
Intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.

Universal Humeral Nail:
Indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.

Proximal Humeral Nail:
Intended for the fixation of proximal humeral fractures. These implants are intended as a guide to normal healing and are not intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

Universal and Troch Entry Nail:
Intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric/intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric features associated with shaft fractures, pathologic fractures in osteoporotic bone of the trohchanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware. In addition to the above indications, the Universal NAIL, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis.

Rockwood Clavicle Pin:
Intended to be used to repair an acute fracture, malunion or non-union of the clavicle.

Small Bone Fixation System:
For the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges, and the metatarsal bones of the foot.

Kirschner Wires & Steinmann Pins:
Fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Device Description

This submission covers an update to the sterilization parameters of DePuy Orthopaedics' range of metallic internal fracture fixation devices manufactured from Titanium, Stainless Steel and Cobalt Chrome and include the following. No modifications have been made to the devices and they are identical to their predicates.

AI/ML Overview

This is a 510(k) premarket notification for DePuy Orthopaedics' metallic internal fracture fixation devices. The submission concerns an update to the sterilization parameters for these devices, not a new device or a new performance claim for an existing device. Therefore, a clinical study proving device performance against acceptance criteria, as one would typically see for AI/ML devices or novel diagnostic tools, is not applicable to this submission.

The "acceptance criteria" here relate to the sterilization process, and the "study that proves the device meets the acceptance criteria" refers to the sterilization validation studies.

Here's a breakdown of the requested information in the context of this specific 510(k) submission:

Acceptance Criteria and Reported Device Performance (Sterilization)

Acceptance Criteria Category	Specific Criteria (Inferred from context)	Reported Device Performance/Evidence
Sterilization Parameters	The updated sterilization parameters (temperature, time, pressure, etc.) must effectively sterilize the devices to a specified Sterility Assurance Level (SAL), typically 10⁻⁶, and be validated according to industry standards. This implicitly means the devices tolerate the new sterilization cycle without degradation of material properties or function.	"Based on testing per AAMI TIR 12 and ANSI/AAMI ST79, the recommended steam sterilization parameters have been updated." This statement confirms that validation studies were conducted specifically for sterilization using recognized consensus standards. AAMI TIR 12 (`"Sterilization of health care products - Radiation - VDmax method - A guide for the establishing of minimum dose levels for radiation sterilization"`) and ANSI/AAMI ST79 (`"Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities"`) are key standards for sterilization validation.
Substantial Equivalence	The updated devices and their updated sterilization parameters must be substantially equivalent to their predicate devices. This means there are no new questions of safety or effectiveness. The core design, material, and indications for use of the devices themselves have not changed.	"The products that are the subject of this submission are equivalent to the predicates. The technological characteristics are identical. Based on testing per AAMI TIR 12 and ANSI/AAMI ST79, the recommended steam sterilization parameters have been updated." This explicitly states equivalence and highlights that only the sterilization parameters were modified, not the device itself.

Additional Requested Information (As applicable to this 510(k) type):

Sample size used for the test set and the data provenance:
- Test Set (for Sterilization Validation): For sterilization validation (as implied by AAMI TIR 12 and ANSI/AAMI ST79), samples of the actual devices (or representative product families) would be used. The typical approach involves biological indicator (BI) testing or bioburden testing. The specific quantitative sample size is not detailed in this 510(k) summary, as it's typically part of the detailed sterilization validation report, not the summary.
- Data Provenance: The testing would be conducted in a laboratory setting, likely at the manufacturer's facility or a contract sterilization validation lab. It is not patient data; it's laboratory-derived data related to the efficacy of the sterilization process on the devices.
- Retrospective or Prospective: This would be prospective validation testing, as the new sterilization parameters need to be verified to meet performance standards before implementation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth (for Sterilization): The "ground truth" in this context is the successful achievement of a specified Sterility Assurance Level (SAL). This is established through established microbiological methods (e.g., negative growth in culture media after exposure to sterilized samples with biological indicators).
- Experts: The validation studies would be designed, executed, and interpreted by microbiologists, sterilization specialists, and regulatory affairs professionals, following recognized standards. Their specific number and qualifications are not detailed in the public 510(k) summary but are part of the internal Quality System documentation and validation reports.
Adjudication method for the test set:
- Adjudication: This concept typically applies to clinical data review or image interpretation. For sterilization validation, there isn't an "adjudication" method in the clinical sense. The results are objective (e.g., growth/no growth of biological indicators, measurement of sterilization parameters). Conformity is determined against predefined pass/fail criteria from the standards (AAMI TIR 12, ANSI/AAMI ST79).
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 submission is for metallic internal fracture fixation devices and an update to their sterilization parameters. It is not an AI/ML device, and therefore, an MRMC comparative effectiveness study is entirely irrelevant to this 510(k).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As stated above, this is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth (for Sterilization): Microbiological sterility (absence of viable microorganisms) confirmed by standardized testing methods (e.g., biological indicator testing, bacteriostasis/fungistasis testing) according to AAMI TIR 12 and ANSI/AAMI ST79 guidelines.
The sample size for the training set:
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. There is no training set for this type of device submission.

Summary

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K111663

510(k) Summary

Submitted by:	DePuy Orthopaedics, Inc.
	700 Orthopaedic Drive
	Warsaw, IN 46581
	Phone: (305) 269-6386
	Fax: (305) 269-6441
Contact Person:	Suzana Otaño, Project Manager, Regulatory Affairs
Date Prepared:	January 31, 2012

General Provisions The names of the devices are:

Proprietary Name	Common or Usual Name
Multiple	Bone Fixation Plates, Intramedullary Nails, Pins, Wires,Screws and Washers

Name of PredicateDevices	The devices are substantially equivalent to their currently marketed versions.The predicate devices are listed below.
Classification	HRS, HWC, HTN, KTT, LXT, HSB, JDW, HTY
PerformanceStandards	Performance standards have not been established by the FDA under section 514of the Food, Drug and Cosmetic Act for these devices.
Device Description	This submission covers an update to the sterilization parameters of DePuyOrthopaedics' range of metallic internal fracture fixation devices manufacturedfrom Titanium, Stainless Steel and Cobalt Chrome and include the following. Nomodifications have been made to the devices and they are identical to theirpredicates.
	K103408, K101421, K082300 Anatomic Locked Plating SystemK093474, K091294 Fracture, LCL and Fusion Plating SystemsK101240 ALPS Small Bone Locked Plating SystemK090877 Proximal Tibia Locking Plating SystemK090492, K083364, K081546 Small Bone Locking Plating SystemK090374 Sterile DVRK083843 Locking Anatomic and Composite Plating SystemK072832 Anterolateral and Medial Locking Plating SystemK072423 4.5mm Locking Broad & Narrow Compression PlatesK072083 Small Fragment Locking Plating SystemK061748 Fragment Plate SystemK060969 Polyax Locked Plating System
	K003235 PERI II Knee Fracture System
	K993465, K981775 Calcaneal Peri-Articular Plate
	K990392 DePuy ACE Spider Plate
	K990120 DePuy ACE TiMax Medial Pilon Plate
	K983853 DePuy ACE TIMAX Meta Plate
	K972629 DePuy ACE TK2 Hip Screw System
	K970503, K950618, K813554 DePuy Ace Trochanteric Side Plate, Supracondylar
	Plate, Captured Hip Screw
	K930592 Universal Reconstruction Plate
	K920738 ACE 100 Degree Tubular Plate
	K905774 Titanium Mini-Plating System
	K905595 ACE Reconstruction Plate
	K060864 Multidirectional Threaded Peg
	K954485 6.5mm solid cancellous bone screw
	K926047 8.0mm cannulated cancellous bone screw
	K903811 ACE cannulated cortical bone screw
	K903810 ACE cannulated self tapping cancellous bone screw
	K874670 ACE Cannulated Self-Tapping cortical bone screw
	K872859 Cancellous bone screw
	K895107 Washers
	K042325 ACE Trochanteric Nail
	K033878 Universal Humeral Nail
	K033806 Proximal Humeral Nail
	K033329 Universal and Troch Entry Nails
	K032097 Tibial Nail
	K023115 VersaNail TTC Fusion Nail
	K003797 TTC Fusion Nail
	K060290 Shoulder Fixation System
	K060294 Diaphyseal Plate
	K893512 Cannulated Bone Screw
	K103001 Rockwood Clavicle Pin
	K041157 Small Bone Fixation System
	K960385 Kirschner Wires & Steinmann Pins

Indications for Use	The indications for use remain unchanged from the existing clearances.
TechnologicalCharacteristics	The technological characteristics of the devices that are the subject of thissubmission remain unchanged from the predicates in terms of design, materialand performance.
Summary ofSubstantialEquivalence	The products that are the subject of this submission are equivalent to thepredicates. The technological characteristics are identical. Based on testing perAAMI TIR 12 and ANSI/AAMI ST79, the recommended steam sterilizationparameters have been updated.

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K111663.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue. Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

DePuy orthopaedics, Incorporated % Ms. Suzana Otano Regulatory Affairs Project Manager 700 Orthopaedics Drive Warsaw, Indiana 46581-0988

MAR 1 2 2012

Re: K111663

Trade/Device Name: DePuy Internal Fixation Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC, HTN, KTT, LXT, HSB, JDW, HTY Dated: February 2, 2012 Received: February 3, 2012

Dear Ms. Otano:

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.

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.

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Page 2 - Ms. Suzana Otano

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 11/663

TTC Fusion Nail Device Name:

Indications For Use:

Intended for use in intramedullary fixation of supracondylar fractures of the femur, including those with severe comminution and intraarticular involvement, osteoporosis, nonunions, malunions, pathologic and fractures proximal to total knee arthroplasty or prosthesis. The TTC Fusion Nail is also indicated for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement, absent talus (tibio calcaneal arthrodesis); post traumatic/primary arthrosis involving both ankle and subtalar joints; a rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total arthroplasty.

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

Over-the-Counter_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

Page 1 of 1 .

Sterilization Parameters for the DePuy Internal Fixation Systems Traditional 510(k) K111663

510(k) Number

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ાતા (૧૯૯)

Small Bone Locked Plating System Device Name:

Indications For Use:

Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

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

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(
Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Sterilization Parameters for the DePuy Internal Fixation Systems Traditional 510(k) K111663

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« 11/6/3

Device Name:

TTC Fusion Nail

Indications For Use:

Intended for use in tibiocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Indications also include non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.

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

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

D. R. Bond

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K116603

Page 1 of 1

Sterilization Parameters for the DePuy Internal Fixation Systems Traditional 510(k) K111663

Page 74 of 93

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111663

Spider Plate Device Name:

Indications For Use:

· Fixation of metaphyseal fractures of the distal tibia
· Proximal metaphyseal tibial fractures
Calcaneus fractures
Proximal humeral head/shaft fractures
· Distal femur fracture -- comminuted shaft fractures
· Fixation of soft tissue, such as tendon and ligaments, to bone

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

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

for (Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K11663
---------------	--------

Page 1 of 1

{8}------------------------------------------------

K111663

Reconstruction & Straight Plate Device Name:

Indications For Use:

Small bone plates (3.5mm):

For intra-articular distal tibial fractures and those of the humeral head; for fractures of the fibula, lateral malleolus, metatarsals and metacarpals, olecranon and distal humerus; for application to the palmar surface of the distal radius and fractures of the olecranon and distal tibia; for application to the dorsum of the distal radius; fractures of the calcaneus; fractures of the radius and ulna; for pelvic and acetabular reconstructive surgery

Large bone plates (4.5, 6.5mm):

For use on the tibia, femur and humerus; for use on the anterior aspect of the distal tibia; for use as a tension band on the proximal humerus and as a buttress on the medial tibial plateau; for use as a buttress on the lateral tibial plateau; for use on fractures of the pelvis and acetabulum; for fractures of the distal humerus; for use as a tension band plate on the radius, ulna and fibula

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

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
for Division of Surgical, Orthopedic, and Restorative Devices

Delle
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K111663

{12}------------------------------------------------

Device Name:

Universal Reconstruction Plate

K111663

Indications For Use:

The 3.5mm plate may be used for fractures of the clavicle, scapula, distal humerus, acetabulum and pelvis.

The 4.5mm plate is intended for use in the following types of fractures: pelvic fractures and acetabular fractures.

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

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oaul
(Director, Sign Off)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number

Sterilization Parameters for the DePuy Internal Fixation Systems Traditional 510(k) K111663

{13}------------------------------------------------

KIJI663

Anatomic Locked Plating System Device Name:

Indications For Use:

For fixation of fractures, fusions, osteotomies and non-unions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone

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

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dree

(Division Stan Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111663

{14}------------------------------------------------

K111663

Fracture and Fusion Plating System Device Name:

Indications For Use:

Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 – 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Prescription Use_ (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Rahul
(Division Sign Off)

Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

. Page 1 of 1

510(k) Number K111663

{15}------------------------------------------------

KIII 663

LCL and Fusion Plating System Device Name:

Indications For Use:

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

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number

{16}------------------------------------------------

KIJ1663

510(k) Number:

Proximal Tibia Locking Plating System Device Name:

Indications For Use:

Intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures.

Prescription Use_ (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Danul
(Division Sign-Off)

(Division Sign-Oft)
Division of Surgical, Orthopedic,.
and Restorative Devices

Page 1 of 1

510(k) Number K111663

{17}------------------------------------------------

KII/663 510(k) Number:

Small Bone Locking Plating System Device Name:

Indications For Use:

For stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

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

Over-the-Counter_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Raul
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111663

Page 1 of 1

Sterilization Parameters for the DePuy Internal Fixation Systems Traditional 510(k) K111663

Page 47 of 93

{18}------------------------------------------------

KU) 6 € 7 510(k) Number:

Sterile DVR Device Name:

Indications For Use:

Intended for fixation of fractures and osteotomies involving the distal radius

Prescription Use_ (Per 21 CFR 801 Subpart D) AND/OR

· Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number Y11663.

{19}------------------------------------------------

Device Name:

Locking Anatomic and Composite Plating System

Indications For Use:

For fixation of fractures, osteotomies and non-unions of the fibula, malleolus, metatarsals and metacarpais, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna and distal tibia, particularly in osteopenic bone.

Intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qlove

Page 1 of 1

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K11663

{23}------------------------------------------------

KII 663

510(k) Number:

Fragment Plate System Device Name:

Indications For Use:

Intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton.

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

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daul
(Division Sign-Off)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number
K111663

{24}------------------------------------------------

ાલા ૯૮૩

Polyax Locked Plating System Device Name:

Indications For Use:

Intended for use in cases requiring stabilization of malunions, non-unions, and osteotomies of the distal femur and proximal tibia and Open Reduction Internal Fixation (ORIF) repair of closed and open fractures of the distal femur and proximal tibia including, but not limited to the following: periarticular fractures, such as simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression fractures with associated shaft fractures, and periprosthetic fractures.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

D. Boudre

Division Sign-Off) Co Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number

{25}------------------------------------------------

510(k) Number:	K111663
Device Name:	Multidirectional Threaded Peg

Indications For Use:
Intended for the fixation of fractures and osteotomies involving the distal radius

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

Over-the-Counter_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oul
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K111663

{26}------------------------------------------------

KIJ663 .

{30}------------------------------------------------

િતાજિક

K///663

Titanium Mini-Plating System Device Name:

Indications For Use:

For plating of maxillofacial fractures or for other small bone fractures (fracture fixation) as determined by the surgeon

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

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

{36}------------------------------------------------

《川台灣

510(k) Number:

Cannulated Cortical Bone Screw Device Name:

Indications For Use:

Fracture fixation of long bones

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

D. Soule

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number C111663

{37}------------------------------------------------

Device Name:

Cannulated Self-tapping Cancellous Bone Screw

Indications For Use:

Fracture fixation of long bones

111667

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

T.J. O'Shea

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number E111663

{38}------------------------------------------------

KIJ1663

Device Name:

Cannulated Self-tapping Cortical Bone Screw

Indications For Use:

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K111663

{43}------------------------------------------------

« | | | 663

Device Name:

Tibial Nail

Indications For Use:

Intended for bone fixation in the management of fracture and reconstructive surgeries.

Non-weight bearing bone fixation is indicated in the following conditions:

Transverse, oblique, spiral, segmental and comminuted fractures; .
Fractures with bone loss and bone transport; .
Open fractures, pathologic fractures; .
Corrective osteotomies; .
Pseudarthrosis of the tibial shaft; .
Nonunions, malunions, metaphyseal and epiphyseal fractures. .

Prescription Use_X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number Kill 6663

Page 1 of 1

{44}------------------------------------------------

Washer Device Name:

Indications For Use:

Intended to be used in conjunction with bone screws

K11663

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) (Division Sign-On)
Tivision of Surgical, Orthopedic, and Kestorative Devices

510(k) Number K110663

{45}------------------------------------------------

1111663

Device Name:

Trochanteric Nail

Indications For Use:

Intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.

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

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Que

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111663

Page 1 of 1

Sterilization Parameters for the DePuy Internal Fixation Systems Traditional 510(k) K111663

Page 77 of 93

{46}------------------------------------------------

Device Name:

Universal Humeral Nail

(11663

Indications For Use:

Indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.

Prescription Use_ (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------	--

((Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number D110663

Page 1 of 1

{47}------------------------------------------------

BOT

Device Name:

Proximal Humeral Nail

Indications For Use:

Intended for the fixation of proximal humeral fractures. These implants are intended as a guide to normal healing and are not intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

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

Over-the-Counter_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K-1116663

Sterilization Parameters for the DePuy Internal Fixation Systems Traditional 510(k) K111663

Page 79 of 93

{48}------------------------------------------------

Universal and Troch Entry Nail Device Name:

KINGC3

Indications For Use:

Intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric/intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric features associated with shaft fractures, pathologic fractures in osteoporotic bone of the trohchanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware. In addition to the above indications, the Universal NAIL, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis.

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

Over-the-Counter (21 CFR 801 Subpart C)

(Please Do Not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Cond
Com, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number
K111663

Page 1 of 1

510(k) Number

{49}------------------------------------------------

KII)

510(k) Number:

Device Name:

Rockwood Clavicle Pin

Indications For Use:

Intended to be used to repair an acute fracture, malunion or non-union of the clavicle.

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

Over-the-Counter_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K110663

{50}------------------------------------------------

Device Name:

Small Bone Fixation System

1111662

Indications For Use:

For the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges, and the metatarsal bones of the foot.

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

Over-the-Counter_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111663

{51}------------------------------------------------

KIII 63

Device Name:

Kirschner Wires & Steinmann Pins

Indications For Use:

Fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Page 1 of 1

Division of Survice!. Orthopedic, and Restorative Devices

510(k) Number K111063

Regulation Number and Section

§ 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.