510(k) · Cleared
ClearedIntegra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · HRS Plate, Fixation, Bone
Cleared on Jul 27, 2021 as substantially equivalent to K152527 (Ascension Orthopedics, 2015) and 10 other predicates after a 204-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Jul 27, 2021
- Review
- 204 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 10 generations to K962616 (1996). 103 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK162153 Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation…Ascension Orthopedics · 2017
- This deviceK210016 Integra DigiFuse Cannulated Intramedullary Fusion System,Integra…Integra LifeSciences Corporation · 2021
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK162153 Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation…Ascension Orthopedics · 2017
- This deviceK210016 Integra DigiFuse Cannulated Intramedullary Fusion System,Integra…Integra LifeSciences Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −1 | K162153 | Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System | Ascension Orthopedics | 2017 | — |
| 0 (this device) | K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot… | Integra LifeSciences Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 10 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 7 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 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? (11)
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 | Decided |
|---|---|---|---|
| * | K152527 | Integra DigiFuse Cannulated Intramedullary Fusion SystemSummary page 7…1. HRS - Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030) Classification Class Il Predicate Device Primary Predicate 1. K152527 — Integra DigiFuse Cannulated Intramedullary Fusion System Additional predicates are as follows and identified with the correspo… | 2015 |
| * | K123000 | Integra Total Foot SystemsSummary page 7…Intramedullary Fusion System Additional predicates are as follows and identified with the corresponding reference from the previous sections of this 510(k) summary. 2. K123000 - Integra Total Foot System 3. K162153 — Integra Capture Internal Fixation System & Integra Ti6 Internal Fixation System 4, K96… | 2012 |
| * | K162153 | Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemSummary page 7…predicates are as follows and identified with the corresponding reference from the previous sections of this 510(k) summary. 2. K123000 - Integra Total Foot System 3. K162153 — Integra Capture Internal Fixation System & Integra Ti6 Internal Fixation System 4, K960692 — Subtalar MBA System 5. K111265 —… | 2017 |
| * | K960692 | Subtalar Mba SystemSummary page 7…ections of this 510(k) summary. 2. K123000 - Integra Total Foot System 3. K162153 — Integra Capture Internal Fixation System & Integra Ti6 Internal Fixation System 4, K960692 — Subtalar MBA System 5. K111265 — MetaSurg Subtalar Implant 6. K011262 — NewDeal BOLD Screw 7. KO083154 — NewDeal HALLU Lock… | 1996 |
| * | K111265 | Metasurg Subtalar ImplantSummary page 7…. K123000 - Integra Total Foot System 3. K162153 — Integra Capture Internal Fixation System & Integra Ti6 Internal Fixation System 4, K960692 — Subtalar MBA System 5. K111265 — MetaSurg Subtalar Implant 6. K011262 — NewDeal BOLD Screw 7. KO083154 — NewDeal HALLU Lock Plate System 8. K093781 — NewDeal… | 2011 |
| * | K011262 | Modification to the Bold ScrewSummary page 7…. K162153 — Integra Capture Internal Fixation System & Integra Ti6 Internal Fixation System 4, K960692 — Subtalar MBA System 5. K111265 — MetaSurg Subtalar Implant 6. K011262 — NewDeal BOLD Screw 7. KO083154 — NewDeal HALLU Lock Plate System 8. K093781 — NewDeal HALLU Plates 9. KO071639 — QWIX Positi… | 2001 |
| * | K083154 | Newdeal Hallu Lock Plate SystemSummary page 7…l Fixation System & Integra Ti6 Internal Fixation System 4, K960692 — Subtalar MBA System 5. K111265 — MetaSurg Subtalar Implant 6. K011262 — NewDeal BOLD Screw 7. KO083154 — NewDeal HALLU Lock Plate System 8. K093781 — NewDeal HALLU Plates 9. KO071639 — QWIX Positioning Screw 10. KO11946 — SPIN Sn… | 2009 |
| * | K093781 | Modified: Newdeal Hallu PlatesSummary page 7…tion System 4, K960692 — Subtalar MBA System 5. K111265 — MetaSurg Subtalar Implant 6. K011262 — NewDeal BOLD Screw 7. KO083154 — NewDeal HALLU Lock Plate System 8. K093781 — NewDeal HALLU Plates 9. KO071639 — QWIX Positioning Screw 10. KO11946 — SPIN Snap-Off Screw 11. K073375 — NewDeal TIBIAXYS Sy… | 2010 |
| * | K071639 | Qwix Positioning ScrewSummary page 7…A System 5. K111265 — MetaSurg Subtalar Implant 6. K011262 — NewDeal BOLD Screw 7. KO083154 — NewDeal HALLU Lock Plate System 8. K093781 — NewDeal HALLU Plates 9. KO071639 — QWIX Positioning Screw 10. KO11946 — SPIN Snap-Off Screw 11. K073375 — NewDeal TIBIAXYS System Classification Panel Orthoped… | 2007 |
| * | K011946 | The Spin Snap-Off Screw | 2001 |
| * | K073375 | Newdeal Tibiaxys SystemSummary page 7…BOLD Screw 7. KO083154 — NewDeal HALLU Lock Plate System 8. K093781 — NewDeal HALLU Plates 9. KO071639 — QWIX Positioning Screw 10. KO11946 — SPIN Snap-Off Screw 11. K073375 — NewDeal TIBIAXYS System Classification Panel Orthopedic Device Description The purpose of this submission is the addition o… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 20 of the 103 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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 DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include: • Hammer toe deformity • Claw toe deformity • Mallet toe deformity • Other deformities of the feet and hands The DigiFuse® implants are intended for single use only. Integra(r) total foot system is indicated for skeletally mature patients for the following…
Read the full statement (767 words)
The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
Indications include:
• Hammer toe deformity
• Claw toe deformity
• Mallet toe deformity
• Other deformities of the feet and hands
The DigiFuse® implants are intended for single use only.
Integra(r) total foot system is indicated for skeletally mature patients for the following:
-stabilization and fixation of fresh fractures
-intra and extra articular fractures, joint depression, and multi-fragmentary fractures
-revision procedures, joint fusion, and reconstruction of small bones of the feet.
The indications for use for the Integra® CAPTURE™ Screw System are as follows: “The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses, and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
The indications for use for the Integra® Ti6® Internal Fixation System are as follows: “The Ti6® Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
The Subtalar MBA System is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela.
*Severely pronated foot
*Walking intemperence
*Calcaneal stance position great than 5 degrees
*Manually correctable deformities
*Mid-tarsal breech (arch pain)
*Forefoot varus greater than 10 degrees
The metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and meical displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Indications include:
severe pronation
Calcaneal valgus deformity
plantarflexed talus
failed correction with long term orthotic treatment
congenital and painful flatfoot deformity
repair of tarsal coalitions
subtalar instability
posterior tibial tendon dysfunction
paralytic flat foot deformity
The metasurg subtalar implants are intended for single use only.
The "new" bold screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- fixation of small bone fragments, in long bones or small bones fractures.
- arthrodesis in hand or foot surgery
- mono or bi-cortical osteotomies in the foot or hand
- distal or proximal metatarsal or metacarpal osteotomies
- fixation of osteotomies for hallux valgus treatment (such as scarf, chevron, etc.)
The hallu lock plates are intended for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Including cases of:
hallux rigidus
severe hallux valgus (im angle>20 degrees and hv angle >40 degrees)
deformity from rheumatoid arthritis
failed previous surgical procedures
traumatic arthritis
neuromuscular instability
the hallu lock plates must be fixed with the surfix fixed angle locking system and with the surfix-alpha variable angle locking system of 2.7mm or 3.0mm diameter (scews and lock-screws). Addition of a newdeal qwix screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
the hallu plates are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metastarso-phalangeal joint, including cases of:
hallux rigidus
severe hallux valgus (im angle > 20 degree and hv angle >40 degree)
deformity from rheumatoid arthritis
failed previous surgical procedure
traumatic arthritis
neuromuscluar instability
The plates have to be fixed with the snap-off screws. Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
The qwix positioning screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
* mono or bi-cortical osteotomies in the foot or hand (including hallux valgus treatment)
* fractures management in the foot or hand
* fixation of bone fragments in long bones or small bones fractures
*arthrodesis in hand, foot and ankle surgery
The size of the chosen screw should be adapted to the specific indication.
The "new" spin" snap-off screw is indicated for fixation of bone fractures of for bone reconstruction.
Examples include:
- fixation of small bone fragments
- weil osteomy
- mono-cortical fixation
- osteotomies and fractures fixation in the foot and hand.
The Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula.
The Newdeal TIBIAXYS Plates have to be fixed with the SURFIX and SURFIX ALPHA 3.5mm diameter Locking System (screws and Lock screws).
Anterior plates for ankle Arthrodesis have to be fixed with the TIBIAXYS 4.0mm diameter cortical screws.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210016: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210016
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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