510(k) · Cleared
ClearedAFFINITY Proximal Tibia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techfit Digital Surgery, Inc. · HRS Plate, Fixation, Bone
Cleared on Mar 21, 2022 as substantially equivalent to K132554 (Aap Implantate AG, 2013) and 5 other predicates after a 56-day review. Its family tree reaches back 14 generations to 1979.
- Decided
- Mar 21, 2022
- Review
- 56 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K792022 (1979). 172 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations between
- 3 generations backK140769 Variax 2 SystemStryker Trauma AG · 2014
- 2 generations backK162841 VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH · 2017
- 1 generation backK191641 AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable…Industrias Medicas Sampedro S.A.S · 2019
- This deviceK220199 AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc. · 2022
Show all 14 generations
- Root · 14 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 13 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 12 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 11 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 10 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 9 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 8 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 7 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 6 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 5 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 4 generations backK132502 Variax 2 SystemStryker Trauma AG · 2013
- 3 generations backK140769 Variax 2 SystemStryker Trauma AG · 2014
- 2 generations backK162841 VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH · 2017
- 1 generation backK191641 AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable…Industrias Medicas Sampedro S.A.S · 2019
- This deviceK220199 AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −13 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −12 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −11 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −10 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −9 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −8 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −7 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −6 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −5 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| −4 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| −3 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| −2 | K162841 | VariAx Distal Radius Plating System, VariAx 2 System | Stryker GmbH | 2017 | — |
| −1 | K191641 | AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle… | Industrias Medicas Sampedro S.A.S | 2019 | — |
| 0 (this device) | K220199 | AFFINITY Proximal Tibia System | Techfit Digital Surgery, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 16 | 0 |
| 1997 | 6 | 0 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 12 | 0 |
| 2001 | 13 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (6)
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 |
|---|---|---|---|
| * | K132554 | Aap Loqteq Proximal Medial Tibia Plate 3.5Summary page 4…Predicate device: Trade or proprietary or model name aap LOQTEQ® Proximal Tibia Plate 3.5 System 510(k) number K132554 Decision date 10/03/2013 Product code HRS Manu… | 2013 |
| * | K171808 | TDM Plate and Screw SystemSummary page 4…nal Predicate device 1 Trade or proprietary or model name TDM Plate and Screw System 510(k) number K171808 Decision date 03/15/2018 Product code… | 2018 |
| * | K191641 | AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Summary page 5…l Predicate device 2 Trade or proprietary or model name AFFINITY – Variable Angle Distal Radius System 510(k) number K191641 Decision date 09/16/2019 Product code HRS, HWC Manu… | 2019 |
| * | K203282 | TECHFIT Patient-Specific Maxillofacial SystemSummary page 5…al Predicate device 3 Trade or proprietary or model name TECHFIT Patient-Specific Maxillofacial System 510(k) number K203282 Decision date 05/19/2021 Product code JEY Manufactu… | 2021 |
| * | K043185 | Synthes 3.5MM Cortex ScrewsSummary page 5…Dental Additional Predicate device 4 Trade or proprietary or model name SYNTHES 3.5mm Cortex Screws 510(k) number K043185 Decision date 02/03/2005 Product code HWC Manufactu… | 2005 |
| * | K123964 | Axsos 3 TI Locking Plate SystemSummary page 5…ic Additional Predicate device 5 Trade or proprietary or model name AXSOS 3 TI Locking Plate System 510(k) number K123964 Decision date 03/28/2013 Product code HRS Manufactu… | 2013 |
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 43 years and passes through 12 companies; a new generation was cleared every 1.9 years on median.
- 30 of the 172 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. 2022, 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?
AFFINITY Proximal Tibia System is intended to treat fractures, nonunions, malunions of the proximal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
Simple metaphyseal fractures (Classification AO 41-A2)
Multifragmentary metaphyseal fractures (Classification AO 41-A3)
Simple bicondylar fractures (Classification AO41-C1, 41-C2)
Multifragmentary bicondylar fractures (Classification AO 41-C3)
Simple joint, simple metaphyseal fractures (Classification AO 41-C1)
Diaphisary fractures (Classification AO 42A and 42B)
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/K220199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220199: AFFINITY Proximal Tibia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220199
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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