# K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Solutions Limited
- Decided: Feb 7, 2012 after 237 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K000684 (2000). 70 ancestors in all.
58 later devices descend from it; 8 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022325: Normed Titanium Osteotomy Plating System, Osteomedics, Inc. (2002) Summary page 1.
- K022324: Normed Titanium Calcaneus Plating with Locking Screw System, Osteomedics, Inc. (2002) Summary page 1.
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 1.
- K100359: Darco Headed Cannulated Screw, Wrightmedicaltechnologyinc (2010) Summary page 1.
- K070031: Memometal Memory Staples, Memometal Technologies (2007) Summary page 1.
- K060746: Memory Staple, DePuy Orthopaedics, Inc. (2006) Summary page 1.
- K964226: Memory Staple (20 Sizes Available), Landos, Inc. (1997) Summary page 1.
- K061798: Biopro Memory Staple, Biopro, Inc. (2006) Summary page 1.
- K092670: Biodrive Micro Screw System, Ebi,Llc D/B/A Biomet Trauma (2009) Summary page 1.
- K050681: Omnitech System & Easy Lock Osteosystem with Xtremities Plates, TriMed, Inc. (2005)
- K043059: Compression Staple and Simple Staple, Wrightmedicaltechnologyinc (2005) Summary page 1.
- K071479: Sbi Stafix, Small Bone Innovations, Inc. (2007) Summary page 1.
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 1.
- K050819: Charlotte Snap-Off Screw, Wrightmedicaltechnologyinc (2005) Summary page 1.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 1.
- K963118: Extremity Bone Screw, Acu Med, Inc. (1996) Summary page 1.
- K060026: Koby Surgical Internal Fixation System, Koby Surgical (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K042583: Calc-I-Oss, Ultradent Products, Inc. (2005). Our reading of the summary gave K042583, FDA’s number for Calc-I-Oss (Ultradent Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “TwistliX Snap-Off Screws System — Wright Medical Tech.”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K141784: Ortho Solutions Ultos Plating System (2014), 28 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own
- K193222: Tyber Medical Anatomical Plating System (2020), 11 descendants of its own
- K172617: Treace Medical Concepts (TMC) Compression Screw System (2017), 11 descendants of its own

## Recalls of this device
- Jul 21, 2016 · Class II · Z-2835-2016: Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.

## Indications for use
The intended use of the Ortho Solutions Extremity Fixation Implants for Osteosynthesis System of bundled fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing. The Ortho Solutions Extremity Fiation Implants for Osteosvnthesis System are used in adult patients. The Ortho Solutions Foot Plating System (FPS) is indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of the feet, ankles, and toes skeleton. The Ortho Solutions Memo Staple System is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis. The Memo Staple is also indicated for use in fixation of soft tissue to bone such as anterior cruciate reconstruction. The Ortho Solutions Foot steotomy System (FOS) is indicated for alignment and stabilization of small bone fractures including: fixation of small bones, such as those inthe foot, ankle, and for treatment of fractures, non-unions, or mal-unions; ligament reconstructions; osteochondritis dissecans; arthrodesis of the foot and ankle; small bone osteotomies, including first metatarsal head osteotomy and metatarsal osteotomies. The Ortho Solutions Staples System are indicated for fixation of bone fractures or bone reconstruction. The Staples are also indicated for use in fixation of soft tissue to bone. The Ortho Solutions Compression Screws System are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The Ortho Solutions Twist~ixT Snap)-Off Screws System are indicated for fixation of bone fractures or for bone reconstruction. Examples include: 1) Fixation of small bone fragments, 2) Weil Osteotomy, 3) Mono-cortical fixation, and 4) Osteotomies and fractures fixation in the foot and hand. The Ortho Solutions Extremity Fixation System (EFSJ of a low profile head screw is indicated for use in fixation of small bone fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand or foot. The Ortho Solutions Extremity Fixation Implants for Osteosynthesis System is not intended for spinal use.

Source page: https://510kreport.com/device/K111678
Methodology: https://510kreport.com/methodology