510(k) · Cleared
Recalled · Class II · 2026Straight Plate with Angular Stability & Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I.T.S. Implantat-Technologie-Systeme GmbH · HRS Plate, Fixation, Bone
Cleared on Mar 20, 2006 as substantially equivalent to K050852 (I.T.S. Implantat-Technologie-Systeme GmbH, 2005) and 6 other predicates after a 59-day review. Its family tree reaches back 7 generations to 1996. 27 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 20, 2006
- Review
- 59 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 9
Its longest line of descent runs back 7 generations to K962616 (1996). 36 ancestors in all, the oldest K890939 (1989). 27 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 1 generation backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- This deviceK060156 Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006
- Descendant · cites it directly · 9 of its ownK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- Descendant · cites it directly · 9 of its ownK063166 I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
- Descendant · cites it directly · 8 of its ownK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
- Descendant · 2 generations on · 4 of its ownK161904 GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017
- Descendant · 2 generations on · 4 of its ownK122538 Acumed Pelvic Bone Plate SystemAcumed, LLC · 2012 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015 · cites it directly9descendants
- K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · cites it directly9descendants
- K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011 · cites it directly8descendants
- K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017 · 2 generations on4descendants
- K122538Acumed Pelvic Bone Plate SystemAcumed, LLC · 2012 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −6 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −5 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −4 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −1 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| 0 (this device) | K060156 | Straight Plate with Angular Stability & Screw System | I.T.S. Implantat-Technologie-Systeme GmbH | 2006 | — |
| +1 | K150693 | PHIN-FX Cannulated Lag Screw System | Ascent Medical, LLC | 2015 | — |
| +1 | K063166 | I.T.S. Pelvic Reconstruction System | I.T.S. Implantat-Technologie-Systeme GmbH | 2006 | 2 |
| +1 | K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | Ortho Solutions Limited | 2011 | — |
| +2 | K161904 | GEO Bone Screw System | Gramercy Extremity Orthopeidics, LLC | 2017 | — |
| +2 | K122538 | Acumed Pelvic Bone Plate System | Acumed, LLC | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2020 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 0 |
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 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050852 | Claviculaplate with Angular Stablity Bone Plate SystemSummary page 1…DEVICE PRODUCT CODE: HRS SUBSEQUENT PRODUCr CODE: HWC, HTN SUNSTANIIALLY I.T.S. GntbH Claviculapilae with Angular Stability (K050852) Smith & Nephew Peri-Leo Locking Bone Plaim and Locldng Bone Screw System (K… | 2005 |
| * | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySummary page 1…culapilae with Angular Stability (K050852) Smith & Nephew Peri-Leo Locking Bone Plaim and Locldng Bone Screw System (K051735) EQUI'VAIZNT PO VICES Zimmer Pcrim'licular Locking Plate and Screws (Kt51098) Synthes 4.Smm LCP Stra… | 2005 |
| Kept off the family tree | K051098 | FDA’s K051098 is Periarticular Locking Plates and Screws, Model 2358 Series Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
| * | K051986 | Synthes 4.5 MM LCP Straight Reconstruction Plates Our reading of the summary gave K051916, FDA’s number for Polar Cath Peripheral Dilatation System (Cryo Vascular Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes 4.5mm LCP Straight Reconstruction Plate”. | 2005 |
| * | K012655 | Congruent Bone Plate SystemSummary page 1…Locking Plate and Screws (Kt51098) Synthes 4.Smm LCP Straigkt Rstrnucton Plate&(K051916) Acurned Congment Plate System (K012655) I.TS. Crbit FkO.. Calmnau. Repair System (I(051642) Syntles Serile 3.5mam and… | 2001 |
| * | K051642 | FR.O.H. Calcaneus Repair SystemSummary page 1…Straigkt Rstrnucton Plate&(K051916) Acurned Congment Plate System (K012655) I.TS. Crbit FkO.. Calmnau. Repair System (I(051642) Syntles Serile 3.5mam and 4.0mm Cannulated Screw (1(963192) Zimmer/Pioneer Cau… | 2005 |
| * | K963192 | Synthes Sterile 3.5 MM and 4.0 MM Cannulated ScrewsSummary page 1…ystem (K012655) I.TS. Crbit FkO.. Calmnau. Repair System (I(051642) Syntles Serile 3.5mam and 4.0mm Cannulated Screw (1(963192) Zimmer/Pioneer Caunui-ted Screw Systrea (K003496) Synthes (USA) Spherical Wash… | 1996 |
| * | K003496 | Cannulated Screw SystemSummary page 1…System (I(051642) Syntles Serile 3.5mam and 4.0mm Cannulated Screw (1(963192) Zimmer/Pioneer Caunui-ted Screw Systrea (K003496) Synthes (USA) Spherical Washers (KXO24S3) DEVICE DESCIUTION: The ITS. Straight Plate with An.ler… | 2001 |
| Kept off the family tree | K024853 | Synthes (USA) Spherical Washers Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (27)
See all 277 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150693 | PHIN-FX Cannulated Lag Screw System | 2015 | 9 |
| K063166 | I.T.S. Pelvic Reconstruction System | 2006 | 9 |
| K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | 2011 | 8 |
| K161894 | SurgTech Trauma System | 2017 | 3 |
| K130008 | Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous… | 2013 | 1 |
| K093868 | I.T.S. LRS Locking Reconstruction System | 2010 | 1 |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular… | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 23, 2026 | Class II | Z-1598-2026 | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| Jan 23, 2026 | Class II | Z-1599-2026 | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 11 of the 36 ancestors have a recall of any class.
- Of its descendants, K150693 (Ascent Medical, LLC, 2015) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K050852.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Intended use of the I.T.S. Straight Plate with Angular Stability is to stabilize an osteotomy or fracture of small bones, long bones, the pelvis and the calcaneus in an adult or pediatric patient. Indications for use include comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. And, as well, a fracture or osteotomy of the tibia, fibula, femoral…
Read the full statement (297 words)
The Intended use of the I.T.S. Straight Plate with Angular Stability is to stabilize an osteotomy or fracture of small bones, long bones, the pelvis and the calcaneus in an adult or pediatric patient.
Indications for use include comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. And, as well, a fracture or osteotomy of the tibia, fibula, femoral condyle, acetabulum, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation. The 3.5mm Cortical and Cancellous Angle Stable Screws used in conjunction with the Straight Plate may only be used on small bones.
The Intended use of the I.T.S. Screw System is for corrective osteotomy or internal fracture fixation of the patella, pelvis, ankle, and long bones in an adult or pediatric patient.
For the 4.0mm Cannulated Cancellous Screw indications for use are for radial and ulnar fractures, fractures of the proximal/distal humerus and of the patella, and for tendon fixation, Maisonneuve injuries and disruption of the syndesmosis with bimalleolar or supramalleolar fractures and the instability of the talus centering.
For the 6.5mm Cannulated Cancellous Screw, indications for use are for fractures of the femoral neck, tibial plateau, of the sacrum and the articular cavity of the hip joint, and the metaphyseal fractures of the distal femur and distal tibia, fixation of the ilio-sacral joint, and fusion of the foot and ankle.
For the 7.3mm Cannulated Cancellous Screw, indications for use are for fractures of the calcaneus, femoral neck, tibial plateau, and of the sacrum and the articular cavity of the hip joint, fusion of the foot and ankle, fixation of the ilio-sacral joint, and metaphyseal fractures of the distal femur and distal tibia.
The system(s) is not intended for spinal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060156 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060156: Straight Plate with Angular Stability & Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060156
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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