510(k) · Cleared

Cleared

Ortho Solutions Trauma Implants for Osteosynthesis

K110895510(k) TraditionalCleared Dec 19, 2011264-day reviewClass II21 CFR 888.3040

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

Ortho Solutions Limited · HWC Screw, Fixation, Bone

Cleared on Dec 19, 2011 as substantially equivalent to K961522 (Synvasive Technology, Inc., 1996) and 16 other predicates after a 264-day review. Its family tree reaches back 8 generations to 1996. 8 later devices descend from it.

Decided: Dec 19, 2011
Review: 264 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 17

Its longest line of descent runs back 8 generations to K962616 (1996). 92 ancestors in all, the oldest K792022 (1979). 8 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
2 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
1 generation backK060156 Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
This deviceK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
Descendant · cites it directly · 3 of its ownK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · Recalled
Descendant · cites it directly · 2 of its ownK150889 Suture Wires and Wire LoopsZimmer, Inc. · 2015
Descendant · 2 generations on · 1 of its ownK203773 BRM TOOL ScrewsBrm Extremities Srl · 2022
Descendant · 2 generations on · 1 of its ownK151848 Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready…Zimmer, Inc. · 2016
Descendant · 3 generations on · 0 of its ownK261271 Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015high 2 (2015) · low 0 (2018)2026

Most influential descendants

Showing 5 of 8 · See all

K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · cites it directly3descendants
K150889Suture Wires and Wire LoopsZimmer, Inc. · 2015 · cites it directly2descendants
K203773BRM TOOL ScrewsBrm Extremities Srl · 2022 · 2 generations on1descendant
K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc. · 2016 · 2 generations on1descendant
K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System	Synthes (Usa)	1996	—
−7	K982732	Synthes (Usa) Distal Radius Plate System (DRPS)	Synthes	1998	—
−6	K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2002	—
−5	K030198	Hand Innovations, Inc. Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−4	K032705	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−3	K050932	Distal Volar Radius Anatomical Plate System	Hand Innovations, Inc.	2005	1
−2	K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	—
−1	K060156	Straight Plate with Angular Stability & Screw System	I.T.S. Implantat-Technologie-Systeme GmbH	2006	2
0 (this device)	K110895	Ortho Solutions Trauma Implants for Osteosynthesis	Ortho Solutions Limited	2011	—
+1	K163489	OrthoSolutions 'System26' Bone Screws	Ortho Solutions UK Limited	2017	1
+1	K150889	Suture Wires and Wire Loops	Zimmer, Inc.	2015	—
+2	K203773	BRM TOOL Screws	Brm Extremities Srl	2022	—
+2	K151848	Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle…	Zimmer, Inc.	2016	—
+3	K261271	Cable-Ready® Cable Grip System	Pioneer Surgical Technology, Inc.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1981	1	0
1989	3	0
1990	3	0
1991	1	0
1992	2	0
1993	3	0
1994	2	0
1995	3	0
1996	11	0
1998	3	0
1999	3	0
2000	10	0
2001	7	0
2002	5	0
2003	5	0
2004	5	0
2005	5	0
2006	4	0
2007	1	0
2008	1	0
2009	3	0
2010	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	2	0
2016	1	0
2017	1	0
2022	2	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K110895, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (17)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K961522	Kirschner Wire (K-Wire) and Steinmann Pin Summary page 1 …HWC SUBSEQUENT PRODUCT CODE: JDW, JDQ, HTY, HTN SUBSTANTIALLY K-Wires & Steinman Pins - Synvasive Technology (K961522) EQUIVALENT DEVICES K-Wires & Steinman Pins - DePuy (K(960385) Pins - Treu-lnstruinente (1(0…	Synvasive Technology, Inc.	1996	—
*	K960385	Sterile Kirschner Wires and Steinmann Pins Summary page 1 …JDW, JDQ, HTY, HTN SUBSTANTIALLY K-Wires & Steinman Pins - Synvasive Technology (K961522) EQUIVALENT DEVICES K-Wires & Steinman Pins - DePuy (K(960385) Pins - Treu-lnstruinente (1(083912) Orthopedic Wire - Howmedica Osteonic…	Depuy, Inc.	1996	—
*	K083912	Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins Summary page 1 …nman Pins - Synvasive Technology (K961522) EQUIVALENT DEVICES K-Wires & Steinman Pins - DePuy (K(960385) Pins - Treu-lnstruinente (1(083912) Orthopedic Wire - Howmedica Osteonics (1K031127) K-Wire - BioPro, Inc. (…	Treu-Instrumente GmbH	2009	—
*	K031127	Orthopedic Wire Summary page 1 …es & Steinman Pins - DePuy (K(960385) Pins - Treu-lnstruinente (1(083912) Orthopedic Wire - Howmedica Osteonics (1K031127) K-Wire - BioPro, Inc. (K(083490) K-Wires, Steinman Pins, Calibrated Pins…	Howmedica Osteonics Corp.	2003	1
*	K083490	Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685 Summary page 1 …Pins - Treu-lnstruinente (1(083912) Orthopedic Wire - Howmedica Osteonics (1K031127) K-Wire - BioPro, Inc. (K(083490) K-Wires, Steinman Pins, Calibrated Pins -Implant Resource (1(002125) Rus…	Biopro, Inc.	2009	—
*	K002125	Pins and Wires Summary page 1 …steonics (1K031127) K-Wire - BioPro, Inc. (K(083490) K-Wires, Steinman Pins, Calibrated Pins -Implant Resource (1(002125) Rush Pin - Onyx Medical (K(903261) K-Wires - Medartis AG (K(092038)…	Implant Resource, Inc.	2000	—
*	K903261	Rush Pin Summary page 1 …, Inc. (K(083490) K-Wires, Steinman Pins, Calibrated Pins -Implant Resource (1(002125) Rush Pin - Onyx Medical (K(903261) K-Wires - Medartis AG (K(092038) Orthopedic Wire - Osteo Technology (K(9…	Onyx Medical Corp.	1990	—
*	K092038	Aptus K-Wire System Summary page 1 …an Pins, Calibrated Pins -Implant Resource (1(002125) Rush Pin - Onyx Medical (K(903261) K-Wires - Medartis AG (K(092038) Orthopedic Wire - Osteo Technology (K(925447) Cann. Screws & Washers - a…	Medartis AG	2009	—
*	K925447	Oti Orthopedic Wire System Summary page 1 …Rush Pin - Onyx Medical (K(903261) K-Wires - Medartis AG (K(092038) Orthopedic Wire - Osteo Technology (K(925447) Cann. Screws & Washers - aap Implantate AG (K021233 & K080101) Cannulate…	Osteo Technology, Inc.	1993	—
*	K021233	Aap Cannulated Screws Summary page 1 …Medartis AG (K(092038) Orthopedic Wire - Osteo Technology (K(925447) Cann. Screws & Washers - aap Implantate AG (K021233 & K080101) Cannulated Screws & Washers - I.T.S. GmbH (1(060156) Cannulate…	Aap Implantate AG	2002	—
*	K080101	Aap Cannulated Screw and Darco Headed Screw Summary page 1 …AG (K(092038) Orthopedic Wire - Osteo Technology (K(925447) Cann. Screws & Washers - aap Implantate AG (K021233 & K080101) Cannulated Screws & Washers - I.T.S. GmbH (1(060156) Cannulated Screws &…	Aap Implantate AG	2008	—
*	K060156	Straight Plate with Angular Stability & Screw System Summary page 1 …5447) Cann. Screws & Washers - aap Implantate AG (K021233 & K080101) Cannulated Screws & Washers - I.T.S. GmbH (1(060156) Cannulated Screws & Washers - Wright Medical (1(100359) Cannulated Screw…	I.T.S. Implantat-Technologie-Systeme GmbH	2006	2
*	K100359	Darco Headed Cannulated Screw Summary page 1 …3 & K080101) Cannulated Screws & Washers - I.T.S. GmbH (1(060156) Cannulated Screws & Washers - Wright Medical (1(100359) Cannulated Screws & Washers - Pioneer/Zimmer (1(102903) Cannulated Screw…	Wrightmedicaltechnologyinc	2010	—
*	K102903	Pioneer Cannulated Screw System Summary page 1 …1(060156) Cannulated Screws & Washers - Wright Medical (1(100359) Cannulated Screws & Washers - Pioneer/Zimmer (1(102903) Cannulated Screws - DePuy/ACE (K90381 0 & 1K90381 1) Cannulated Screws -…	Pioneer Surgical Technology, Inc.	2010	—
*	K903810	Ace Cannulated Self Tapping Cancellous Bone Screw Summary page 1 …Wright Medical (1(100359) Cannulated Screws & Washers - Pioneer/Zimmer (1(102903) Cannulated Screws - DePuy/ACE (K90381 0 & 1K90381 1) Cannulated Screws - Synthes (K(963172)…	Ace Medical Co.	1990	—
*	K903811	Ace Cannulated Cortical Bone Screw Summary page 1 …cal (1(100359) Cannulated Screws & Washers - Pioneer/Zimmer (1(102903) Cannulated Screws - DePuy/ACE (K90381 0 & 1K90381 1) Cannulated Screws - Synthes (K(963172) Page 1…	Ace Medical Co.	1990	—
*	K963172	Synthes Sterile 4.5 MM Cannulated Screws Summary page 1 …s - Pioneer/Zimmer (1(102903) Cannulated Screws - DePuy/ACE (K90381 0 & 1K90381 1) Cannulated Screws - Synthes (K(963172) Page 1 of 3 Section XII Ortho S…	Synthes (Usa)	1996	—

Also cleared against K961522: 2 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K163489	OrthoSolutions 'System26' Bone Screws	Ortho Solutions UK Limited	2017	3
K150889	Suture Wires and Wire Loops	Zimmer, Inc.	2015	2
K150626	Rush Medullary Pins	Zimmer, Inc.	2015	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
16 of the 92 ancestors have a recall of any class.
Of its descendants, K163489 (Ortho Solutions UK Limited, 2017) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K961522.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The intended use of the Ortho Solutions Trauma Implants for Osteosynthesis System is to draw two or more aligned bone fragments together to facilitate healing. Ortho Solutions K-Wires. Steinman Pins. Guide Pins Fixation Pins. & Rush Pins are indicated for use in fixation of bone fractures, for bone reconstruction, for skeletal traction in alignment of long bone fractured segments, and as guide pins & wires for insertion of other implants. Ortho Solutions…

Read the full statement (281 words)

The intended use of the Ortho Solutions Trauma Implants for Osteosynthesis System is to draw two or more aligned bone fragments together to facilitate healing.

Ortho Solutions K-Wires. Steinman Pins. Guide Pins Fixation Pins. & Rush Pins are indicated for use in fixation of bone fractures, for bone reconstruction, for skeletal traction in alignment of long bone fractured segments, and as guide pins & wires for insertion of other implants.

Ortho Solutions Cerclape Wire is indicated for use for bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures where other treatments or devices have been unsuccessful, and bone reconstruction procedures.

Ortho Solutions Cannulated Bone Screws and Washers are indicated for use over a guide pin or wire for aligned bone fracture fixation and bone fragment fixation. Washers of matching size to the cannulated bone screw may be used in certain applications. Cannulated bone screw sizes (with optional washer) of 4.0mm, 4.5mm, 5.0mm, 6.5mm, and 8.0mm are to be used with large and long bones in the skeletal anatomy. Specific indications, which are dependent in part on the diameter of the screw include: Minimally invasive fracture/joint reconstructions; Additive osteosynthesis for complex joint fractures; Multiple-fragment joint fractures; Femoral neck and femoral head fractures; Femoral supracondylar fractures; Tibial plateau fractures; Fractures of the head of the humerus & tibia; Cooper fractures of the tibia; Fractures of radius, wrist, ankle, elbow, and shoulder; Ligament fixation of the proximal humerus; Fractures of the acetabulum and dorsal pelvic ring; Condylar. fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Fractures of the calcaneus and talus; Arthrodesis of the ankle joint; and Avulsion fractures.

The Ortho Solutions Trauma Implants for Osteosynthesis System is not intended for spinal use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110895 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110895: Ortho Solutions Trauma Implants for Osteosynthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110895

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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