510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Ortho Solutions Extremity Fixation Implants for Osteosysnthesis

K111678510(k) TraditionalCleared Feb 7, 2012237-day reviewClass II21 CFR 888.3030Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ortho Solutions Limited · HRS Plate, Fixation, Bone

Cleared on Feb 7, 2012 as substantially equivalent to K022325 (Osteomedics, Inc., 2002) and 16 other predicates after a 237-day review. Its family tree reaches back 7 generations to 2000. 58 later devices descend from it. It has been recalled once.

Decided
Feb 7, 2012
Review
237 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
18

Its longest line of descent runs back 7 generations to K000684 (2000). 70 ancestors in all, the oldest K792022 (1979). 58 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 2 other ancestors2009: 1 other ancestor2008: 2 other ancestors2007: 2 other ancestors2006: 5 other ancestors2005: 5 other ancestors2002: 7 other ancestors1997: 1 other ancestor1996: 8 other ancestors2003: 2 other ancestors2001: 4 other ancestors2000: 2 other ancestors1999: 4 other ancestors1979: 1 other ancestor1995: 3 other ancestors1994: 2 other ancestors1993: 1 other ancestor1992: 4 other ancestors1990: 1 other ancestor1980: 1 other ancestor1991: 1 other ancestor1989: 3 other ancestors1981: 1 other ancestor2024: 8 descendants cleared2015: 6 descendants cleared2017: 6 descendants cleared2013: 1 descendant cleared2014: 2 descendants cleared2022: 3 descendants cleared2026: 7 descendants cleared2020: 4 descendants cleared2016: 1 descendant cleared2019: 2 descendants cleared2025: 5 descendants cleared2023: 9 descendants cleared2021: 4 descendants clearedK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled×2: 2 generations cleared close together, K011335 (2001), K012655 (2001) K021626 · Hallu Plates · New Deal, S.A. · 2002K040907 · Arthrex Small Fragment Plates and Screws · Arthrex, Inc. · 2004K052614 · Low Profile Plate and Screw System · Arthrex, Inc. · 2005K103705 · Low Profile Screws · Arthrex, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 16 other ancestors2 generations back: 13 other ancestors3 generations back: 21 other ancestors4 generations back: 13 other ancestors 1 generation forward: 8 descendants2 generations forward: 16 descendants3 generations forward: 14 descendants4 generations forward: 11 descendants5 generations forward: 5 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant K103705 · Low Profile Screws · Arthrex, Inc. · 2011K052614 · Low Profile Plate and Screw System · Arthrex, Inc. · 2005K040907 · Arthrex Small Fragment Plates and Screws · Arthrex, Inc. · 2004K021626 · Hallu Plates · New Deal, S.A. · 2002K012655 · Congruent Bone Plate System · Acu Med, Inc. · 2001 · recalledK011335 · Synths One-Third Tubular DCL Plate · Synthes (Usa) · 2001 · recalledK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled−50+5
  1. Root · 7 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
  2. 6 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
  3. 5 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
  4. 4 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
  5. 3 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
  6. 2 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
  7. 1 generation backK103705 Low Profile ScrewsArthrex, Inc. · 2011
  8. This deviceK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012
  9. Descendant · cites it directly · 28 of its ownK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
  10. Descendant · cites it directly · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
  11. Descendant · cites it directly · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
  12. Descendant · 2 generations on · 11 of its ownK193222 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020
  13. Descendant · 2 generations on · 11 of its ownK172617 Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2013: 12014: 22015: 62016: 12017: 62019: 22020: 42021: 42022: 32023: 92024: 82025: 52026: 7
2013high 9 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 58 · See all
  • K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · cites it directly28descendants
  • K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · cites it directly24descendants
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · cites it directly19descendants
  • K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020 · 2 generations on11descendants
  • K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017 · 2 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K000684Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa)20001
−6K011335Synths One-Third Tubular DCL PlateSynthes (Usa)20012
−5K012655Congruent Bone Plate SystemAcu Med, Inc.200116
−4K021626Hallu PlatesNew Deal, S.A.2002—
−3K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004—
−2K052614Low Profile Plate and Screw SystemArthrex, Inc.2005—
−1K103705Low Profile ScrewsArthrex, Inc.2011—
0 (this device)K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012—
+1K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited20142
+1K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH20132
+1K162674BioPro Foot Plating SystemsBiopro, Inc.2017—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC2020—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198110
198930
199010
199110
199240
199310
199420
199530
199680
199710
199940
200020
200140
200270
200320
200550
200650
200720
200820
200910
201020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201420
201560
201610
201760
201920
202040
202140
202230
202390
202480
202550
202670
FIG. 1 — Lineage of K111678, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (18)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K022325Normed Titanium Osteotomy Plating System
Summary page 1
…CODE: HIRS SUBSEQUENT PRODUCT CODE: JDR, HWC SUBSTANTIALLY 'Foot Plating System' Ascension Orthopedics (K(022325, 1(022324) EQUIVALENT DEVICES 'Foot Plating System' Wright Medical Tech. (K(061808, K(100359)…
Osteomedics, Inc.20021
*K022324Normed Titanium Calcaneus Plating with Locking Screw System
Summary page 1
…HIRS SUBSEQUENT PRODUCT CODE: JDR, HWC SUBSTANTIALLY 'Foot Plating System' Ascension Orthopedics (K(022325, 1(022324) EQUIVALENT DEVICES 'Foot Plating System' Wright Medical Tech. (K(061808, K(100359) 'Me…
Osteomedics, Inc.20021
*K061808Darco Locking Bone Plate System
Summary page 1
…UBSTANTIALLY 'Foot Plating System' Ascension Orthopedics (K(022325, 1(022324) EQUIVALENT DEVICES 'Foot Plating System' Wright Medical Tech. (K(061808, K(100359) 'Memo Staple System' Memtometal Technologies (K070031) '…
Darco International, Inc.20063
*K100359Darco Headed Cannulated Screw
Summary page 1
…LY 'Foot Plating System' Ascension Orthopedics (K(022325, 1(022324) EQUIVALENT DEVICES 'Foot Plating System' Wright Medical Tech. (K(061808, K(100359) 'Memo Staple System' Memtometal Technologies (K070031) 'Memo Stapl…
Wrightmedicaltechnologyinc2010—
*K070031Memometal Memory Staples
Summary page 1
…QUIVALENT DEVICES 'Foot Plating System' Wright Medical Tech. (K(061808, K(100359) 'Memo Staple System' Memtometal Technologies (K070031) 'Memo Staple System' DePuy Orthopedics (K060746, K(964226) 'Memo S…
Memometal Technologies2007—
*K060746Memory Staple
Summary page 1
…8, K(100359) 'Memo Staple System' Memtometal Technologies (K070031) 'Memo Staple System' DePuy Orthopedics (K060746, K(964226) 'Memo Staple System' Biopro (K(061798) 'Foot Osteoomy Sy…
DePuy Orthopaedics, Inc.2006—
*K964226Memory Staple (20 Sizes Available)
Summary page 1
…) 'Memo Staple System' Memtometal Technologies (K070031) 'Memo Staple System' DePuy Orthopedics (K060746, K(964226) 'Memo Staple System' Biopro (K(061798) 'Foot Osteoomy System' Biom…
Landos, Inc.1997—
*K061798Biopro Memory Staple
Summary page 1
…ologies (K070031) 'Memo Staple System' DePuy Orthopedics (K060746, K(964226) 'Memo Staple System' Biopro (K(061798) 'Foot Osteoomy System' Biomet/EBI (K(092670) 'Foot Osteotomy Syste…
Biopro, Inc.2006—
*K092670Biodrive Micro Screw System
Summary page 1
…Orthopedics (K060746, K(964226) 'Memo Staple System' Biopro (K(061798) 'Foot Osteoomy System' Biomet/EBI (K(092670) 'Foot Osteotomy System' TriMed (1(05068 1) 'Staples System' Wright…
Ebi,Llc D/B/A Biomet Trauma2009—
*K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.2005—
*K043059Compression Staple and Simple Staple
Summary page 1
…em' Biomet/EBI (K(092670) 'Foot Osteotomy System' TriMed (1(05068 1) 'Staples System' Wright Medical Tech. (K043059) 'Staples System' Small Bone Innovations (K(071479) 'Compression Sc…
Wrightmedicaltechnologyinc2005—
*K071479Sbi Stafix
Summary page 1
…iMed (1(05068 1) 'Staples System' Wright Medical Tech. (K043059) 'Staples System' Small Bone Innovations (K(071479) 'Compression Screws System' Wright Medical Tech. (K082320) 'Twistl…
Small Bone Innovations, Inc.2007—
*K082320Darco Small Screw
Summary page 1
…43059) 'Staples System' Small Bone Innovations (K(071479) 'Compression Screws System' Wright Medical Tech. (K082320) 'TwistliXTM Snap-Off Screws System' Wright Medical Tech. (K(050819,…
Wrightmedicaltechnologyinc2008—
*K050819Charlotte Snap-Off Screw
Summary page 1
…on Screws System' Wright Medical Tech. (K082320) 'TwistliXTM Snap-Off Screws System' Wright Medical Tech. (K(050819, K(042583) 'Extremity Fixation System' Arthrex (K(103705, K963118)…
Wrightmedicaltechnologyinc2005—
Kept off the family treeK042583FDA’s K042583 is Calc-I-Oss
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
…System' Wright Medical Tech. (K082320) 'TwistliXTM Snap-Off Screws System' Wright Medical Tech. (K(050819, K(042583) 'Extremity Fixation System' Arthrex (K(103705, K963118) 'Extremity…
Ultradent Products, Inc.2005—
*K103705Low Profile Screws
Summary page 1
…XTM Snap-Off Screws System' Wright Medical Tech. (K(050819, K(042583) 'Extremity Fixation System' Arthrex (K(103705, K963118) 'Extremity Fixation System' Ascension Orthopedics (K(060026)…
Arthrex, Inc.2011—
*K963118Extremity Bone Screw
Summary page 1
…-Off Screws System' Wright Medical Tech. (K(050819, K(042583) 'Extremity Fixation System' Arthrex (K(103705, K963118) 'Extremity Fixation System' Ascension Orthopedics (K(060026) 'Extr…
Acu Med, Inc.1996—
*K060026Koby Surgical Internal Fixation System
Summary page 1
…'Extremity Fixation System' Arthrex (K(103705, K963118) 'Extremity Fixation System' Ascension Orthopedics (K(060026) 'Extremity Fixation System' Acumed (K(963118) OS Extremity Fixation Implants for Osteosysnthe…
Koby Surgical2006—

Also cleared against K022325: 4 other devices →

What descends from it? (58)

See all 58

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited201428
K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH201324
K162674BioPro Foot Plating SystemsBiopro, Inc.201719
K151407RECON systemNormed Medizin-Technik GmbH20154
K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited20173
K142057Infix Cannulated Screw SystemInfix Medical, LLC20151
K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240
K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 21, 2016Class IIZ-2835-2016Labeling mix-upsMislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 12 of the 70 ancestors have a recall of any class.
  • Of its descendants, K141784 (Ortho Solutions Limited, 2014) has gone furthest, with 28 descendants of its own.
  • 4 other devices also cite its predicate K022325.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

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…

Read the full statement (326 words)

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.

Indications for use as stated in the FDA summary.

Also cleared against K022325

4 other devices cite the same predicate.

  • K151407RECON systemNormed Medizin-Technik GmbH · 2015
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  • K061808Darco Locking Bone Plate SystemDarco International, Inc. · 20063 recalls
  • K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004

More from Ortho Solutions Limited

6 FDA decisions under this applicant name. See the company

  • K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 20142 recalls
  • K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited · 20121 recall
  • K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012
  • K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
  • K102743Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresOrtho Solutions Limited · 2011

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K111678 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111678

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026