510(k) Report

510(k) · Cleared

Cleared

Accin Hip System

K073068510(k) TraditionalCleared Jan 10, 200872-day reviewClass II21 CFR 888.3358

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

Accelerated Innovation, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 10, 2008 as substantially equivalent to K935484 (Stelkast Company, 1994) and 6 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1994. 28 later devices descend from it.

Decided
Jan 10, 2008
Review
72 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K934162 (1994). 7 ancestors in all. 28 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1999: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2010: 3 descendants cleared2015: 2 descendants cleared2014: 4 descendants cleared2016: 1 descendant cleared2018: 2 descendants cleared2021: 2 descendants cleared2019: 1 descendant cleared2022: 3 descendants cleared2017: 3 descendants cleared2025: 1 descendant cleared2026: 3 descendants cleared2023: 2 descendants cleared2024: 1 descendant clearedK934162 · Proform HA Hip System · Stelkast Company · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors 1 generation forward: 3 descendants2 generations forward: 12 descendants3 generations forward: 5 descendants4 generations forward: 6 descendants5 generations forward: 2 descendants K934162 · Proform HA Hip System · Stelkast Company · 19940+5
  1. Root · 1 generation backK934162 Proform HA Hip SystemStelkast Company · 1994
  2. This deviceK073068 Accin Hip SystemAccelerated Innovation, LLC · 2008
  3. Descendant · cites it directly · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
  4. Descendant · 2 generations on · 16 of its ownK143407 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014
  5. Descendant · 2 generations on · 14 of its ownK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
  6. Descendant · 3 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
  7. Descendant · 3 generations on · 6 of its ownK173104 Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD®…Total Joint Orthopedics, Inc. · 2017

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2010: 32014: 42015: 22016: 12017: 32018: 22019: 12021: 22022: 32023: 22024: 12025: 12026: 3
2010high 4 (2014) · low 0 (2011)2026

Most influential descendants

Showing 5 of 28 · See all
  • K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · cites it directly25descendants
  • K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014 · 2 generations on16descendants
  • K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014 · 2 generations on14descendants
  • K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 3 generations on9descendants
  • K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc. · 2017 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934162Proform HA Hip SystemStelkast Company1994—
0 (this device)K073068Accin Hip SystemAccelerated Innovation, LLC2008—
+1K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.2010—
+2K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.2014—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.2014—
+3K163577Ecofit® Hip SystemImplantcast GmbH20171
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low…Total Joint Orthopedics, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610
199910
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201440
201520
201610
201730
201820
201910
202120
202230
202320
202410
202510
202630
FIG. 1 — Lineage of K073068, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 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? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K935484Provident Hip System
Summary page 1
…FR 888.3358, Class I1and 87 HWC and screw, fixation, bone, 21 CFR 888.3040, Class II Predicate Device: Provident Hip System - K935484, K946371, K960180, K991622 K001745, and K002796 and Stelkast Bone Screws - K934162 Device Descrip…
Stelkast Company1994—
*K946371Provident HP System
Summary page 1
…58, Class I1and 87 HWC and screw, fixation, bone, 21 CFR 888.3040, Class II Predicate Device: Provident Hip System - K935484, K946371, K960180, K991622 K001745, and K002796 and Stelkast Bone Screws - K934162 Device Description:…
Stelkast Company1995—
*K96018022 MM Cocr Head & Polyethlene Liner
Summary page 1
…I1and 87 HWC and screw, fixation, bone, 21 CFR 888.3040, Class II Predicate Device: Provident Hip System - K935484, K946371, K960180, K991622 K001745, and K002796 and Stelkast Bone Screws - K934162 Device Description:…
Stelkast Company1996—
*K99162226 MM Cast Cocr Head and Polyethylene Acetabular Shell Liner
Summary page 1
…HWC and screw, fixation, bone, 21 CFR 888.3040, Class II Predicate Device: Provident Hip System - K935484, K946371, K960180, K991622 K001745, and K002796 and Stelkast Bone Screws - K934162 Device Description:…
Stelkast Company1999—
*K001745Modification to Provident Hip System
Summary page 1
…screw, fixation, bone, 21 CFR 888.3040, Class II Predicate Device: Provident Hip System - K935484, K946371, K960180, K991622 K001745, and K002796 and Stelkast Bone Screws - K934162 Device Description: T…
Stelkast Company2000—
*K002796Modification to Provident Hip System
Summary page 1
…888.3040, Class II Predicate Device: Provident Hip System - K935484, K946371, K960180, K991622 K001745, and K002796 and Stelkast Bone Screws - K934162 Device Description: T The Accin M Hip Sy…
Stelkast Company2000—
*K934162Proform HA Hip System
Summary page 1
…I Predicate Device: Provident Hip System - K935484, K946371, K960180, K991622 K001745, and K002796 and Stelkast Bone Screws - K934162 Device Description: T The Accin M Hip System consists of plasma spray coate…
Stelkast Company1994—

Also cleared against K935484: 4 other devices →

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025
K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp.20101
K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc.20100

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?

  • None of the 7 ancestors has a recall.
  • Of its descendants, K100445 (Total Joint Orthopedics, Inc., 2010) has gone furthest, with 25 descendants of its own.
  • 4 other devices also cite its predicate K935484.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

The AccinTM Hip System components are for use in total hip arthroplasty as a result of:

* Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint

disease, osteoarthritis and arthritis resulting from biologic or mechanical trauma to the

hip

* Correction of functional deformity

* Avascular necrosis

* Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur

* Difficult clinical management problems involving persistent pain and physical impairment

where conventional arthodesis is not likely to achieve satisfactory results.

These components are single use only and are intended for implantation without bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K935484

4 other devices cite the same predicate.

  • K201733Provident II Hip StemsGlobus Medical, Inc. · 2021
  • K190276Provident II Hip StemStelkast, Inc. · 2019
  • K132158Novohip Total Hip SystemNovosource, Inc. · 20141 recall
  • K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company · 2011

More from Accelerated Innovation, LLC

7 FDA decisions under this applicant name. See the company

  • K081127Accin Total Knee SystemAccelerated Innovation, LLC · 20081 recall
  • K080647Accin Bipolar Head SystemAccelerated Innovation, LLC · 2008
  • K080539Accin Unipolar Head SystemAccelerated Innovation, LLC · 2008
  • K073120Accin Patellofemoral SystemAccelerated Innovation, LLC · 2008
  • K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC · 2008

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K073068 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073068: Accin Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073068

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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